(56 days)
Not Found
No
The summary describes image manipulation and fusion software with quantitative tools, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The focus is on combining and visualizing existing data.
No
The device is described as a "medical diagnostic application" and "image manipulation software" for "viewing, image manipulation, 3D... of medical images," intended for "visualization and comparison of modalities." It provides "analytical tools to help the user visually assess, and document any findings" related to diagnosis and therapy follow-up, but does not provide any therapy itself.
Yes
The "Intended Use / Indications for Use" section states: "syngo TrueD is a medical diagnostic application for viewing, image manipulation, 3Dsyngo Trucib is a modical of medical images." and "syngo TrueD provides analytical tools to help the user visually compare, morphologically or functional activity at diagnostic assess, and document any eningions." These statements directly indicate its use for diagnostic purposes.
Yes
The device description explicitly states, "syngo TrueD will be marketed as a software only solution for the end-user (with recommended hardware requirements)." While it requires hardware to run, the device itself is the software component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states that syngo TrueD is "image manipulation software" that processes "existing datasets from imaging modalities" like PET and SPECT. It works with medical images, not biological samples.
- Intended Use: The intended use is for "viewing, image manipulation, 3D visualization and comparison of medical images." This is focused on interpreting images, not analyzing biological samples.
Therefore, syngo TrueD falls under the category of medical imaging software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
syngo TrueD is a medical diagnostic application for viewing, image manipulation, 3D syngo Trucib is a modical of medical images. syngo TrueD is intended for visualization and companson of modalities and/or multiple time-points into a single datasce that accurately represents the information from the initial data. The a single datasets could be functional 3D volumes (e.g. PET and SPECT) and/or anatomic Input uatascis court be runctional bis "fusion" of data may 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 syngo Truct Chaires Visuanzation of TrueD provides analytical tools to help the user visually compared unformedialy. 97%8 morphological or functional activity at diagnostic assess, and document any eningions. syngo TrueD is designed to support the and therapy fonow-up examination the user to confirm the absence or presence of oncological working evaluation, quantification, follow-up and documentation of any such lesions.
Note: The clinician retains the ultimate responsibility for making the pertinent Note. The enmends returns and practices and visual comparison of the separate unregistered images. syngo TrueD is a complement to these standard procedures.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
syngo TrueD is image manipulation software that is intended to assemble existing datasets from imaging modalities into a single dataset that accurately represents the information from the initial data. This "fusion" of data from multiple modalities will be performed on 3D volume datasets and may be represented in a number of output formats including MIP and volume rendering. Additionally, simple quantitative measurements may be made and subsequently compared to a dataset acquired at a different point in time.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM formatted images. Input datasets could be functional 3D volumes (e.g. PET and SPECT) and/or anatomic.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
K010938, K033374, K010336, K040970
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
510(k) Summary JUL 3 0 2004
This summary of 510(k) safety and effectiveness is provided in accordance with the requirements of SMDA 1990 and 21 CFR §807.92
General Information
Manufacturer Facility (Developer) Siemens Medical Solutions USA, Inc. 51 Valley Stream Pkwy Malvem, PA 19355 Establishment Registration Number: 2240869
Manufacturer Facility (Contract Manufacturer)
Siemens Medical Solutions USA, Inc. 2501 North Barrington Rd. Hoffman Estates, IL 60195-7372 Establishment Registration Number: 1423253
Contact Person
Richard Andersen Manager of Quality Assurance Phone: (610) 448-4362 Fax: (610) 448-4274
Device Name and Classification
| Trade Name: | syngo TrueD |
|---|---|
| Classification Name: | Picture Archiving and Communications System |
| CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | LLZ |
Safety and Effectiveness Information Supporting the Substantial Equivalence Determination
Device Description and Intended Use
syngo TrueD is image manipulation software that is intended to assemble existing datasets from imaging modalities into a single dataset that accurately represents the information from the initial data. This "fusion" of data from multiple modalities will be performed on 3D volume datasets and may be represented in a number of output formats including MIP and volume rendering. Additionally, simple quantitative measurements may be made and subsequently compared to a dataset acquired at a different point in time.
More detailed information regarding the device can be found in the System Description included in Section 2 as well as in the technical information in Section 4.
Technological Characteristics
syngo 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.
1
syngo TrueD supports DICOM formatted images and information. It is based on the Windows XP operating system.
Safety Information
Sarety 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, moonlined with the appropriate preventive measures taken indicate the device is of minor Contonious with the appropriate August 29, 1991 issue of the "Reviewers Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review".
The device has no patient contacting materials and is utilized only by trained The device Thas no pations of the device is evaluated by trained professionals allowing sufficient review for identification and intervention in the event of a malfunction. Device sutten review for receinciente the appropriateness of a referral. The device does not impact the quality or status of the original acquired data.
Substantial Equivalence:
Substantial Equivalentially equivalent, both in intended use and technically, to the following devices:
| Predicate Device Name | FDA Clearance
Number |
|---------------------------------|-------------------------|
| syngo Multimodality Workstation | K010938 |
| Lung CARE CT Software Package | K033374 |
| Advantage Windows CT/PET Fusion | K010336 |
| Leonardo Workstation | K040970 (in review) |
In summary, Siemens is of the opinion that syngo TrueD does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device.
2
Image /page/2/Picture/2 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text around the perimeter reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center appears to be three stylized, abstract shapes that could be interpreted as birds in flight or flowing lines.
JUL 3 0 2004
Food and Drug Administration 00 Corporate Boulevard deville MD 20050
Siemens Medical Solutions USA, Inc. c/o Mr. Glenn Luchen Staff Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Rd. MELVILLE NY 11747-3081
Re: K041484
Trade/Device Name: syngo TrueD Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: July 14, 2004 Received: July 15, 2004
Dear Mr. Luchen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamined the device is substantially equivalent (for the indications ferenced above and naro uses.
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regally actuated the Medical Device Amendments, or 10 commerce provision to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have occh roomssing in avere approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, therefore, market the act include requirements for annual registration, listing of gencial controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device is elassified (500 above) ... Existing major regulations affecting your device can be it may be subject to adament. 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 I Tease oc accermination that your device complies with other requirements of the Act that I DA has made a doler minutions administered by other Federal agencies. You must of any I ederal statules and regulates.
comply with all the Act's requirements, including, but not limited to: registration and listing Comply with an the rioe Frequiremently (1) CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 007), laboming (21 CFR Part 820); and if applicable, the electronic forth in the quality byevelib (sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo lotter 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 the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincercly yours,
Nancy C. Brydon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use
| 510(k) Number (if known): | K041484 |
|---|---|
| Device Name: | syngo TrueD |
Indications For Use:
syngo TrueD is a medical diagnostic application for viewing, image manipulation, 3Dsyngo Trucib is a modical of medical images. syngo TrueD is intended for visualization and companson of modalities and/or multiple time-points into a single datasce that accurately represents the information from the initial data. The a single datasets could be functional 3D volumes (e.g. PET and SPECT) and/or anatomic Input uatascis court be runctional bis "fusion" of data may 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 syngo Truct Chaires Visuanzation of TrueD provides analytical tools to help the user visually compared unformedialy. 97%8 morphological or functional activity at diagnostic assess, and document any eningions. syngo TrueD is designed to support the and therapy fonow-up examination the user to confirm the absence or presence of oncological working evaluation, quantification, follow-up and documentation of any such lesions.
Note: The clinician retains the ultimate responsibility for making the pertinent Note. The enmends returns and practices and visual comparison of the separate unregistered images. syngo TrueD is a complement to these standard procedures.
(Please do not write below this line - continue on another page if needed)
Concurrence of the CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K041484