(92 days)
Not Found
No
The document describes image viewing, manipulation, visualization, and analytical tools for comparison, but does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as a "medical diagnostic application" that supports visualization, analysis, and comparison of medical images for diagnostic and therapy follow-up examinations. It explicitly states its purpose is to "help the user assess, and document changes" and "support the oncological workflow including interpretation and evaluation of examinations, and follow up documentation of findings," rather than to provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "syngo.PET&CT Oncology is a medical diagnostic application". The "Device Description" also reiterates that it is a "medical diagnostic application".
Yes
The device description explicitly states, "The syngo.PET&CT Oncology package is a software only medical device."
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 description: The description clearly states that syngo.PET&CT Oncology is a software application for viewing, manipulating, and analyzing medical images from various imaging modalities (PET, SPECT, CT, MR). It processes data acquired from imaging equipment, not biological samples.
- Intended Use: The intended use focuses on supporting the oncological workflow through image interpretation, evaluation, and documentation of findings based on these images.
Therefore, syngo.PET&CT Oncology falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
syngo.PET&CT Oncology is a medical diagnostic application for viewing, manipulation, 3Dvisualization 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.
syngo.PET&CT Oncology enables visualization of information that would otherwise have to be visually compared disjointedly. syngo.PET&CT Oncology provides analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations.
syngo.PET&CT Oncology is designed to support the oncological workflow including interpretation and evaluation of examinations, and follow up documentation of findings.
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.PET&CT Oncology is a complement to these standard procedures.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The syngo.PET&CT Oncology package is a software only medical device which will be delivered on CD-ROM / DVD to be installed onto the commercially available Siemens syngo.via software platform by trained service personnel.
syngo.PET&CT Oncology is a medical diagnostic application for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PFT 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.PET&CT Oncology enables visualization of information that would otherwise have to be visually compared disjointedly. syngo.PET&CT Oncology provides anaiytical tools to help the user assess, and document changes in morphological or functional activity at day nostic and therapy follow-up examinations.
syngo.PET&CT Oncology is designed to support the oncological workflow including interpretation and evaluation of examinations, and follow up documentation of findings.
The syngo.PET&CT Oncology package is similar to the commercially available TrueD software (K091373), syngoCT Oncology (K071310) and syngo Dual Energy software (K07303) in functionality and usage. syngo. PET&CT Oncology is intended to be run on the Siemens syngo.via software platform (K092519) either alone or with other advanced comment cleared applications.
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
clinician, trained service personnel
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.
K092519, K091373, K073003, K071310
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).
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i
Siemens syngo.PET&CT Oncology 510(k) Premarket Notification
ﻤﺪ
:
Strictly Confidential
. .
as required by 21 CFR Part 807.87(h)
FEB 2 8 2010
ldentification of the Submitter
| Submitter: | M. Alaine Medio, RAC
PET and PCS Regulatory Projects Manager
Siemens Medical Solutions USA, Inc.
Molecular Imaging
810 Innovation Drive
Knoxville, TN 37932 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number: | (865)218-2703 |
| Fax Number: | (865)218-3019 |
| Name / Address of
Manufacturer | Siemens Medical Solutions USA, Inc
Molecular Imaging
2501 N. Barrington Road
Hoffman Estates, IL 60192
USA |
| Date of Submission: | November 20, 2009 |
| Identification of the product | |
| Device Proprietary Name: | syngo.PET&CT Oncology |
| Common Name: | Image Processing Software |
| Classification Name: | Picture Archiving and Communication System per 21
CFR 892.2050 |
| Product Code: | LLZ |
| Classification Panel: | Radiology |
| Device Class: | Class II |
1
Marketed Devices to which Equivalence is claimed
| Device | Manufacturer | 510(k) Number |
|---|---|---|
| syngo.x | ||
| (syngo.via) | Siemens AG, Medical Solutions | K092519 |
| True D | Siemens Medical Solutions USA, | |
| Inc | K091373 | |
| Syngo Dual Energy | Siemens Medical Solutions USA, | |
| Inc. | K073003 | |
| syngoCT Oncology | Siemens Medical Solutions USA, | |
| Inc. | K071310 |
Device Description:
The syngo.PET&CT Oncology package is a software only medical device which will be delivered on CD-ROM / DVD to be installed onto the commercially available Siemens syngo.via software platform by trained service personnel.
syngo.PET&CT Oncology is a medical diagnostic application for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PFT 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.PET&CT Oncology enables visualization of information that would otherwise have to be visually compared disjointedly. syngo.PET&CT Oncology provides anaiytical tools to help the user assess, and document changes in morphological or functional activity at day nostic and therapy follow-up examinations.
syngo.PET&CT Oncology is designed to support the oncological workflow including interpretation and evaluation of examinations, and follow up documentation of findings.
The syngo.PET&CT Oncology package is similar to the commercially available TrueD software (K091373), syngoCT Oncology (K071310) and syngo Dual Energy software (K07303) in functionality and usage. syngo. PET&CT Oncology is intended to be run on the Siemens syngo.via software platform (K092519) either alone or with other advanced comment cleared applications.
2
Safety and Effectiveness:
The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.
Risk Management is ensured via a risk analysis in compliance with ISO 14971:2007 to identify and provide mitigation to potential hazards beginning early in the design cycle and continuing throughout the development of the product. Siemens Medical Solutions, USA Inc. adheres to recognized and established industry standards for development.
Indications for Use:
syngo.PET&CT Oncology is a medical diagnostic application for viewing, manipulation, 3Dvisualization 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.
syngo.PET&CT Oncology enables visualization of information that would otherwise have to be visually compared disjointedly. syngo.PET&CT Oncology provides analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations.
syngo.PET&CT Oncology is designed to support the oncological workflow including interpretation and evaluation of examinations, and follow up documentation of findings.
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.PET&CT Oncology is a complement to these standard procedures.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
FEB 2 3 2010
Ms. Alaine Medio, RAC PET and PCS Regulatory Projects Manager Siemens Medical Solutions USA, Inc. 810 Innovation Drive KNOXVILLE TN 37932-2751
Re: K093621
Trade/Device Name: syngo.PET&CT Oncology Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 20, 2009 Received: November 23, 2009
Dear Ms. Medio:
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 includions for use stated in the enclosure) to legally marketed predicate devices marked 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Amill Jtth
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: syngo.PET&CT Oncology
Indications for Use:
syngo.PET&CT Oncology is a medical diagnostic application for viewing, manipulation, 3Dvisualization 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.
syngo.PET&CT Oncology enables visualization of information that would otherwise have to be visually compared disjointedly. syngo.PET&CT Oncology provides analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations.
syngo.PET&CT Oncology is designed to support the oncological workflow including interpretation and evaluation of examinations, and follow up documentation of findings.
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.PET&CT Oncology is a complement to these standard procedures.
Prescription Use X (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)
CDRH. Office office of ice Evaluation (OBE)
Ond. Kaff.
Divisi h Sign-Off Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of /
510(k) Number K093621
Page 17 of 1167