U.S. Food & Drug Administration 10903 New Hampshire Avenue D o c I D # 0 4 0 1 7 . 0 2 . 0 8 Silver Spring, MD 20993 www.fda.gov

Siemens Healthcare GmbH℅ Mr. Alexander SchapovalovResponsible Third Party Official 510(k) TPR Deputy Program ManagerTÜV SÜD America Inc.1775 Old Highway 8 NWNEW BRIGHTON MN 55112-1891

Re: K180563Trade/Device Name: syngo®.plazaRegulation Number: 21 CFR 892.2050Regulation Name: Picture archiving and communications systemRegulatory Class: Class IIProduct Code: LLZDated: April 11, 2018Received: April 16, 2018

Dear Mr. Schapovalov:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

Page 2 – Mr. Schapovalov K180563

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Robert Ochs, Ph.D.DirectorDivision of Radiological HealthOffice of In Vitro Diagnostics

and Radiological HealthCenter for Devices and Radiological Health

Enclosure

FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below.

510(k) Number (if known)K180563

Device Namesyngo®.plaza

Indications for Use (Describe)syngo .plaza is a Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive digital medical images, including mammographic images. It supports the physician in diagnosis and treatment planning For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images and only preprocessed DICOM "For Presentation" images must be used. Also monitors (displays) and printers which received FDA clearance for Mammography must be used syngo .plaza also supports DICOM Structured Reports In a comprehensive imaging suite, syngo .plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer-specific workflows syngo .plaza optionally uses a variety of advanced postprocessing applications

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov

“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.”

2%risersK 5%%Wm

Traditional 510(k) Summarvsyng0®.plaza VB30

This summary of 510(k) safety and effectiveness information is being submitted inaccordance with the requirements of SMDA 1990 and 21 CFR §807.92.

1. SubmitterSiemens Healthcare GmbHHenkestrasse 12791052 ErlangenGermany

2. Establishment Registration Number

3002808157

3. Contact PersonVij ay RamadasRegulatory Affairs ManagerSiemens Healthcare GmbHHartmanstrasse 1691052 ErlangenGermanyTelephone: +49 172 432 4369Telefax: +49 (9131) 84-8691Email: vijay.ramadas@siemens-healthineers.com

4. Device Name and ClassificationProduct Name: syng0®.plaZaClassification Name: Picture Archiving and Communications SystemClassification Panel: RadiologyCFR Section: 21 CFR §892.2050Device Class: Class IIProduct Code: LLZ

5. Legally Marketed Predicate DeviceProduct Name: syng0®.plaza510(k) Number: K132532Clearance Date December 09, 2013

6. Safety and Effectiveness Information Supporting the Substantial EquivalenceDetermination

6.1 Intended Use

syng0®.plaZa is a Picture Archiving and Communication System intendedto display, process, read, report, communicate, distribute, store, and archivedigital medical images, including mammographic images. It supports thephysician in diagnosis and treatment planning

For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images and only preprocessed DICOM "For Presentation"

510(k) for syng0®.plaza Page J-1

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©Siemens Healthcare GmbH, 2018

images must be used. Also monitors (displays) and printers which receivedFDA clearance for Mammography must be used

syng0®.plaza also supports DICOM Structured Repoits

In a comprehensive imaging suite, syng0®.plaza integrates Hospital / RadiologyInformation Systems (HIS / RIS) to enable customer specific workflows

syng0®. plaza optionally uses a variety of advanced postprocessing applications

6.2 TechnologicalCharacteristicssyngo®.plaZa is a “software only”-system, to be installed on common IThardware, matching the syngo®.plaza hardware requirements.

The above characteristics are also applicable for the predicate devicesyngo®.plaZa VBl0A (K132532)

Page J-2 510(k) for syng0®.plaza

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Clinical Testing

No clinical studies were carried out for syng0®.plaza, all performance testing wasconducted in a non-clinical fashion as part of the verification and validationactivities fir the medical device

Non-Clinical Performance Testing

The software verification and validation was performed for the complete systemaccording the following standards:

- ISO 1497l:2007- IEC 62304 Edition 1.1 2015-06

- IEC 82304-1 Edition 1.1 2016-10

- IEC 62366-1 Edition 1.0 2015-02

- NEMA PS3 /ISO 12052:2017 (DICOM)- ISO / IEC 10918-l:1994 + TC l:2005

- ISO / IEC 15444-l:2005 + TC 112007- IEEE 3333.2.l:2015

- ISO /HL7 2l73l:2014 (HL7 Version 2.x)

After comparison of the test results with the software release acceptance criteria,Siemens Healthcare GmbH is of the opinion, that syng0®.plaza VB30 issubstantially equivalent to and performs as well as the predicate devicesyng0®. plaza VB 1 OAGeneral Safety and Effectiveness Information

The device labeling contains instructions for use and necessary cautions for safeand effective use of the device. Risk Management was implemented throughoutthe development process to control potential hazards

The device does not come into contact with the patient and is only used by trainedprofessionals. Risk management is ensured via a risk analysis, which is used toidentify potential hazards. These potential hazards are controlled via softwaredevelopment, verification and validation

Siemens Healthcare GmbH believes that syng0®. plaza VB30 is safe and effectiveas the identified predicate device and does not introduce new safety andeffectiveness concerns

Substantial EquivalenceThe syng0®.plaza, addressed in this premarket notification, is substantiallyequivalent to the following commercially available device:

Manufacturer Predicate Device FDA Clearance Number i Clearance Date

Siemens AG Healthcare syng0®.plaza VBIOA Kl32532 i December 09, 2013

The syng0®. plaza described in this 510(k) has the same intended use and similartechnical characteristics as the predicate device listed above in regard to thespecific functionalities.

510(k) for syng0®.plaza Page J-15

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12. ConclusionIn summary, Siemens Healthcare GmbH is of the opinion that syngo®.plaza VB30does not introduce any new potential safety risks and is substantially equivalent to andperforms as well as the predicate device.

Page J-16 510(k) for syng0®.plaza

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