(17 days)
Not Found
No
The document describes standard image processing and viewing software for nuclear medicine, SPECT, PET, and CT images. There is no mention of AI, ML, deep learning, or any related concepts in the intended use, device description, or other sections. The focus is on image acquisition, display, manipulation, and archiving using established protocols.
No.
The device is described as a display and analysis package intended to aid clinicians in the assessment and quantification of pathologies from imaging modalities; it does not directly treat or cure any condition.
Yes
The "Intended Use / Indications for Use" states that the software is "intended to aid the clinician in the assessment and quantification of pathologies." This phrasing directly indicates a diagnostic purpose.
Yes
The device description explicitly states "The proposed device is a software-only update intended for use with nuclear medicine applications." and details its functions as a software interface for image processing and viewing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The description clearly states that Syngo MI Applications 2007A is a software product used with nuclear medicine applications. Its primary function is to acquire, view, manipulate, post-process, and archive images from SPECT, PET, CT, and other imaging modalities. It aids clinicians in the assessment and quantification of pathologies based on these images.
- No Specimen Analysis: There is no mention of the software analyzing biological specimens or providing information derived from such analysis. Its input is imaging data, not biological samples.
Therefore, while it is a medical device used for diagnostic purposes, it falls under the category of medical imaging software rather than an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
SPECT, PET, CT, nuclear medicine, hybrid images
Anatomical Site
Body or organ(s)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare professionals / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
0
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
Manager, Regulatory Affairs | Phone: | (847) 304-7516 |
|----|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|--------|----------------|
| | | | FAX: | (847) 304-6023 |
| | | Siemens Medical Solutions USA, Inc.
Molecular Imaging Group | | |
| | | 2501 N. Barrington Road | | |
| | | Hoffman Estates, IL 60195 | | |
| | | Frank.Pokrop@Siemens.com | | |
| 2. | Date Prepared: | December 14, 2006 | | |
| 3. | Name/Classification
of Device | System, Imaging Processing, Radiological
Class II
Picture Archiving and Communications System
21 CFR Part 892.2050
90 LLZ
Radiology Panel | | |
-
- Trade Name of syngo MI Applications 2007A Proposed Device:
-
- Predicate Devices:
| 510(k) #: | Trade Name | Manufacturer |
|---|---|---|
| K992731 | e.Cam Computer | Siemens Medical |
| Solutions USA, Inc. | ||
| K023190 | e.Cam Computer/ | |
| e.soft Workstation | Siemens Medical | |
| Solutions USA, Inc. | ||
| K041166 | Siemens Enhanced | |
| Imaging System | ||
| (a.k.a., Symbia) | Siemens Medical | |
| Solutions USA, Inc. |
-
- Manufacturer and Distributor:
Siemens Medical Solutions USA, Inc. Molecular Imaging Group 2501 N. Barrington Road Hoffman Estates, IL 60195
- Manufacturer and Distributor:
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Image /page/1/Picture/0 description: The image shows the word "SIEMENS" in bold, black letters. The letters are evenly spaced and appear to be a sans-serif font. The background is white, providing a high contrast for the text.
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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Image /page/2/Picture/0 description: The image shows the word "SIEMENS" in all capital letters. The font is bold and sans-serif. The letters are black against a white background.
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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Image /page/3/Picture/0 description: The image shows the word "SIEMENS" in all capital letters. The font is bold and sans-serif. The letters are black against a white background.
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 |
| functions and modalities | ||
| 2 | Software controlled versions of syngo MI | |
| Applications 2007A | Limited and feature-specific versions of the high-level | |
| program are dedicated to one of the following activities: | ||
| Acquisition, Processing, Viewing, Cardiac only | ||
| 3 | syngo MI Mobile | A mobile version of the high-level program intended for |
| 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, |
| 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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Image /page/4/Picture/0 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUM." arranged around the left side of the circle. To the right of the text is a stylized graphic of three curved lines that appear to be stacked on top of each other. The logo is black and white and appears to be of low resolution.
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.
Image /page/4/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, "FDA" in the center, and "Centennial" at the bottom. There are also three stars below the word "Centennial". The logo appears to be a commemorative emblem for the centennial of the Food and Drug Administration (FDA).
Protecting and Promoting Public Health
5
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 (800) 638-2041 or (240) 276-3150
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
6
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