SYNGO MI APPLICATIONS 2007A

K063826 · Siemens Medical Solutions USA, Inc. · LLZ · Jan 12, 2007 · Radiology

Device Facts

• Record ID: K063826
• Device Name: SYNGO MI APPLICATIONS 2007A
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jan 12, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Syngo MI Applications 2007A is a software product intended for use with nuclear medicine applications. It is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, PET, CT and other imaging modalities. It is used to detect or image the distribution of radionuclides in the body or organ(s) using the following techniques: planar imaging and processing; whole body imaging; tomographic imaging; positron imaging by coincidence; positron imaging without coincidence up to 588 keV; display, process and fusion of nuclear medicine, SPECT, PET, CT and hybrid images.

Device Story

Software-only update for nuclear medicine applications; functions as primary user interface for acquiring, viewing, manipulating, post-processing, and archiving images from Siemens SPECT, PET, SPECT/CT, and PET/CT systems. Operates on standard networking protocols (DICOM, TCP/IP) for integration with PACS, HIS/RIS, and third-party software. Used by healthcare professionals in clinical settings; includes mobile version for remote viewing. Enhancements include Pixon-based planar processing and Flash 3D tomographic processing to improve image analysis, potentially reducing radiation dose or acquisition time. Provides quality control reminders, 64-bit operation, and media viewing capabilities. Output aids clinicians in assessment and quantification of pathologies, facilitating diagnostic decision-making and patient management.

Clinical Evidence

Bench testing only. Verification and validation testing performed to address potential hazards identified through risk analysis. No clinical data provided.

Technological Characteristics

Software-only application; 64-bit architecture. Connectivity via DICOM and TCP/IP. Integrates with PACS, HIS/RIS, and third-party software. Features Pixon proprietary algorithms for planar processing and Flash 3D for tomographic processing. Supports remote maintenance and mobile viewing.

Indications for Use

Indicated for clinicians to assess and quantify pathologies using SPECT, PET, CT, and other imaging modalities. Used to detect or image radionuclide distribution via planar, whole-body, tomographic, and positron imaging (coincidence and non-coincidence up to 588 keV). Supports display, processing, and fusion of nuclear medicine and hybrid images.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• e.Cam Computer (K992731)
• e.Cam Computer/e.soft Workstation (K023190)
• Siemens Enhanced Imaging System (a.k.a., Symbia) (K041166)

Reference Devices

• 4DMSPECT
• Emory
• Neurogam
• Scenium
• Fusion 7D
• IDL
• Cedars

Submission Summary (Full Text)

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JAN 1.2 2007

KD63826

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

As required by 21 CFR part 807.87(h)

| 1. | Submitted By: | Frank Pokrop<br>Manager, Regulatory Affairs | Phone: | [phone] |
|----|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|--------|----------------|
| | | | FAX: | [phone] |
| | | Siemens Medical Solutions USA, Inc.<br>Molecular Imaging Group | | |
| | | 2501 N. Barrington Road | | |
| | | Hoffman Estates, IL 60195 | | |
| | | [e-mail] | | |
| 2. | Date Prepared: | December 14, 2006 | | |
| 3. | Name/Classification<br>of Device | System, Imaging Processing, Radiological<br>Class II<br>Picture Archiving and Communications System<br>21 CFR Part 892.2050<br>90 LLZ<br>Radiology Panel | | |

- 4. Trade Name of syngo MI Applications 2007A Proposed Device:
- 5. Predicate Devices:

| 510(k) #: | Trade Name | Manufacturer |
|-----------|--------------------------------------------------------|----------------------------------------|
| K992731 | e.Cam Computer | Siemens Medical<br>Solutions USA, Inc. |
| K023190 | e.Cam Computer/<br>e.soft Workstation | Siemens Medical<br>Solutions USA, Inc. |
| K041166 | Siemens Enhanced<br>Imaging System<br>(a.k.a., Symbia) | Siemens Medical<br>Solutions USA, Inc. |

- 6. Manufacturer and Distributor:
Siemens Medical Solutions USA, Inc. Molecular Imaging Group 2501 N. Barrington Road Hoffman Estates, IL 60195

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#### PROPOSED DEVICE DESCRIPTION

The proposed device is a software-only update intended for use with nuclear medicine applications. The software functions as the primary user interface for acquiring, viewing, manipulating, post-processing and archiving images from the Siemens family of:

- dedicated SPECT and PET systems, and, .
- SPECT/CT and PET/CT multi-modality systems .

The software collects clinical applications data for digital processing and viewing of images and also provides data and images for later use with third party software applications. Reviewing of images from remote locations is also possible with a limited but mobile version of this program.

The proposed device provides healthcare practitioners the ability to work with Siemens SPECT, PET, CT and other images while using standard networking and image transfer protocols such as DICOM and TCP/IP for connections to and from other devices and imaging stations. Communication capabilities consist of image review and data storage workstations through the use of the PACS protocol. Lastly, the proposed software also works with hardcopy devices, external archive devices and HIS/RIS - or Hospital Information / Radiological Information Systems.

#### DESCRIPTION OF CHANGES OR MODIFICATIONS

The changes made to the proposed device consist of software and performance refinements including:

- (1) More effective processing:
- a. Enhanced planar processing: post processing provides ancillary images based on Pixon® proprietary algorithms. Together with the original images, the Pixon-based images can improve image analysis, allow reduction of dose, allow reduction of acquisition time, or any combination thereof.
- Tomographic processing: Flash 3D can improve image analysis, allow ﺗﻔ reduction of dose, allow reduction of acquisition time, or any combination thereof.
- (2) Built-in quality control reminders so the user can maintain camera performance
- (3) Remote maintenance and software queries
- (4) 64 bit operation
- (5) Mobile viewing with syngo MI Mobile applications
- (6) Image display using syngo Media Viewer
- (7) Functionality with a broad suite of third party software applications

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#### INDICATIONS FOR USE

Syngo M! Applications is a noninvasive software program that is used to acquire, view, manipulate, post-process and archive images from the Siemens gamma cameras, PET instruments and CT systems. It is a medical image and information management system capable of functioning in several distinct methods of operation which are described in this summary.

Syngo MI Applications 2007A is a software product intended for use with nuclear medicine applications. It is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT. PET, CT and other imaging modalities.

It is used to detect or image the distribution of radionuclides in the body or organ(s) using the following techniques:

- . planar imaging and processing
- . whole body imaging and processing
- tomographic imaging and processing .
- positron imaging by coincidence ◆
- positron imaging without coincidence up to 588 keV .
- display, process and fusion of nuclear medicine, PET, . CT and hybrid images.

#### COMPARISON WITH PREDICATE DEVICES

The proposed device will use technology that is similar to the technology already in use by Siemens Medical Solutions. The proposed device uses the same hardware platforms and the same software language like each of the predicate devices. It also has the same intended use and the same indications for use as the predicate devices. Fundamental concepts and principles of operation also remain the same.

A detailed comparison with the predicate devices is included in Section 11 of the submission. The claim for substantial equivalence is also detailed within this submission.

Syngo MI Applications 2007A as described in this Premarket Notification has the same intended use and similar technical characteristics as the devices listed above and is substantially equivalent to those products.

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## PRODUCTS COVERED IN THIS SUBMISSION

Testing and validation of the following products are covered by this submission:

| | PRODUCT | COMMENT |
|---|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | syngo MI Applications 2007A | A fully featured software product covering all imaging<br>functions and modalities |
| 2 | Software controlled versions of syngo MI<br>Applications 2007A | Limited and feature-specific versions of the high-level<br>program are dedicated to one of the following activities:<br>Acquisition, Processing, Viewing, Cardiac only |
| 3 | syngo MI Mobile | A mobile version of the high-level program intended for<br>remote viewing of images |
| 4 | syngo Media Viewer | For copying and viewing images |
| 5 | Functionality with Third Party Software | 4DMSPECT, Emory, Neurogam, Scenium, Fusion 7D,<br>IDL, Cedars |

### GENERAL SAFETY AND EFFECTIVENESS CONCERNS

The software is intended to be used by appropriately trained health care professionals. The proposed device contains instructions for use as well as the necessary cautions and warnings to provide for safe and effective use of the revice

To identify potential hazards, risk management is ensured through a risk analysis and other tools to appropriately address potential hazards. These potential hazzrds are controlled via software development, verification and validation resting.

In summary, Siemens believes that the software product, syngo MI Applications 2007A does not introduce any potential safety risks and is substantially equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JAN 1 2 2007

Mr. Frank Pokrop Manager, Regulatory Affairs Siemens Medical Solutions USA, Inc. Molecular Imaging Group 2501 North Barrington Road HOFFMAN ESTATES IL 60192-2061

Re: K063826

Trade/Device Name: Syngo MI Applications 2007A Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 15, 2006 Received: December 26, 2006

Dear Mr. Pokrop:

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 Amendronts, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drue, and Normeric Act (Act) that do not require approval of a premarket approval application (PMA). You mosu. 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 adulterstion.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major repulations affectives 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.

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Protecting and Promoting Public Health

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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# SIEMENS

# Indications for Use

510(k) Number (if known):

KO63826

Device Name: Syngo MI Applications 2007A

Indications for Use:

Syngo MI Applications 2007A is a software product intended for use with nuclear medicine applications. It is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, PET, CT and other imaging modalities.

It is used to detect or image the distribution of radionuclides in the body or organ(s) using the following techniques:

- planar imaging and processing .
- whole body imaging
- tomographic imaging
- . positron imaging by coincidence
- positron imaging without coincidence up to 588 keV
- display, process and fusion of nuclear medicine, SPECT, PET, CT and hybrid images.

Prescription Use
(Part 21 CFR 801 Subpart D)

OR

Over the Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063826