(9 days)
No
The summary describes image viewing, manipulation, visualization, and analytical tools, but does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
The device is described as a "medical diagnostic application" that helps visualize and analyze medical images for diagnostic and therapy follow-up examinations and radiation therapy planning, but it does not directly administer therapy.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state multiple times that "syngo TrueD is a medical diagnostic application." It also mentions providing analytical tools for assessing morphology and functional activity at diagnostic examinations and helping to confirm the presence or absence of lesions.
Yes
The device description explicitly states, "TrueD will be marketed as a software only solution for the end-user (with recommended hardware requirements)."
Based on the provided information, syngo TrueD is NOT an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- syngo TrueD's Function: syngo TrueD is a software application that processes and visualizes medical images obtained from imaging modalities like PET, SPECT, CT, and MR. It works with images already acquired from the patient, not with samples taken from the patient.
- Intended Use: The intended use clearly describes image viewing, manipulation, visualization, comparison, and analysis of medical images for diagnostic and therapy follow-up purposes. This is distinct from performing tests on biological samples.
Therefore, syngo TrueD falls under the category of medical imaging software or a picture archiving and communication system (PACS) component, not an IVD.
N/A
Intended Use / Indications for Use
syngo TrueD is a medical diagnostic application for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.
syngo TrueD enables visualization of information that would otherwise have to be visually compared disjointedly. syngo TrueD provides analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations.
syngo TrueD is designed to support the oncological workflow by helping the user to confirm the absence or presence of lesions, including evaluation, quantification, follow-up and documentation of any such lesions. The application allows to store and export volume of interest (VOI) structures in DICOM RT format for use in radiation therapy planning systems.
syngo TrueD allows visualization and analysis of respiratory gated studies to support accurate delineation of the target or treatment volume over a defined phase of the respiratory cycle and thus provide information for radiation therapy planning.
Product codes
LLZ
Device Description
syngo TrueD is a medical diagnostic application for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.
syngo TrueD enables visualization of information that would otherwise have to be visually compared disjointedly. syngo TrueD provides analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations.
syngo TrueD is designed to support the oncological workflow by helping the user to confirm the absence or presence of lesions, including evaluation, quantification, follow-up and documentation of any such lesions. The application allows to store and export volume of interest (VOI) structures in DICOM RT format for use in radiation therapy planning systems.
syngo TrueD allows visualization and analysis of respiratory gated studies to support accurate delineation of the target or treatment volume over a defined phase of the respiratory cycle and thus provide information for radiation therapy planning.
TrueD will be marketed as a software only solution for the end-user (with recommended hardware requirements) . It will be installed by Siemens service engineers. The TrueD described supports DICOM formatted images and information. It is based on the Windows XP operating system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET, SPECT, CT, MR
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals, oncological workflow, diagnostic and therapy follow-up examinations, radiation therapy planning
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)
K071950, K063324, K071964, K032915, K063762
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
KD91373
MAY 20 2009
This summary of 510(k) safety and effectiveness is provided in accordance with the requirements of SMDA 1990 and 21 CFR §807.92
Date Prepared: March 30th, 2009
General Information
Manufacturer Facility (Developer/manufacturer) Siemens Medical Solutions USA, Inc. 20 Valley Stream Pkwy Malvern, PA 19355 Establishment Registration Number: 3002329443
Contact Person
James E. Kuhn Jr. Senior Regulatory Submissions Manager Phone: (610) 448-3006 Fax: (610) 448-4274
Device Name and Classification
Trade Name: Classification Name: CFR Section: Device Class: Product Code:
syngo™ TrueD Software Picture Archiving and Communications System 21 CFR §892.2050 Class II LLZ
Safety and Effectiveness Information Supporting the Substantial Equivalence Determination
Device Description and Intended Use
ﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
syngo TrueD is a medical diagnostic application for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.
syngo TrueD enables visualization of information that would otherwise have to be visually compared disjointedly. syngo TrueD provides analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations.
syngo TrueD is designed to support the oncological workflow by helping the user to confirm the absence or presence of lesions, including evaluation, quantification, follow-up and documentation of any such lesions. The application allows to store and export volume of interest (VOD structures in DICOM RT format for use in radiation therapy planning systems.
1
syngo TrueD allows visualization and analysis of respiratory gated studies to support accurate delineation of the target or treatment volume over a defined phase of the respiratory cycle and thus provide information for radiation therapy planning.
Technological Characteristics
TrueD will be marketed as a software only solution for the end-user (with recommended hardware requirements) . It will be installed by Siemens service engineers. The TrueD described supports DICOM formatted images and information. It is based on the Windows XP operating system.
Safety Information
A summary of the software design description, hazard analysis, and technical and safety information can be found in the attached submission. The results of the hazard analysis, combined with the appropriate preventive measures taken indicate the device is of minor level of concern, as per Guidance for the Content of Premarket Submission for Software Contained in Medical Devices. May 2005
The device has no patient contacting materials and is utilized only by trained professionals. The output of the device is evaluated by trained professionals allowing sufficient review for identification and intervention in the event of a malfunction. Device output and analysis is used to indicate the appropriateness of a referral. The device does not impact the quality or status of the original acquired data.
Substantial Equivalence:
The syngo TrueD Software is substantially equivalent, both in intended use and technically, to the following devices:
| Predicate Device Name | 'DA Clearance Number |
|---|---|
| TrueD | K071950 |
| GE PET VCAR | K063324 |
| MiMVista (Mim Contouring) | K071964 |
| GE Advantage 4D Option | K032915 |
| Siemens syngo Circulation | K063762 |
In summary, Siemens is of the opinion that the indicated change to the syngo TrueD software, as described within this submission does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device.
REV B
2
Image /page/2/Picture/0 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the upper half of the circle, following its curvature. The logo is black and white and appears to be a scanned or printed image.
DEPARTMENT OF HEALTH & HUMAN SERVICES
20 2009 MAY
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Siemens Medical Solution USA, Inc. % Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Rd. NORTHBROOK IL 60062
Re: K091373 .
Trade/Device Name: Syngo™ TrueD Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ · Dated: April 28, 2009 Received: May 11, 2009
Dear Mr. Devine:
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 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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) 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 892.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). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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/cdrh/industry/support/index.html.
Sincerely yours,
[signature]
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
ﺎ ﻟﻠﻌﺐ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ
Page 2
4
Indications for Use
| 510(k) Number (if known): | Not Known K091373 |
|---|---|
| Device Name: | Syngo™ TrueD |
Indications for Use:
syngo TrueD is a medical diagnostic application for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.
syngo TrueD enables visualization of information that would otherwise have to be visually compared disjointedly. syngo TrueD provides analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations.
syngo TrueD is designed to support the oncological.workflow by helping the user to confirm the absence or presence of lesions, including evaluation, quantification, follow-up and documentation of any such lesions. The application allows to store and export volume of interest (VOI) structures in DICOM RT format for use in radiation therapy planning systems.
syngo TrueD allows visualization and analysis of respiratory gated studies to support accurate delineation of the target or treatment volume over a defined phase of the respiratory cycle and thus provide information for radiation therapy planning.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo Truen in a complement to these standard procedures.
Prescription Use (Part 21 CFR 801 Subpart D)
AND / OR
Over-The-Counter-Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal an Radiological Devi 510(k) Number
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