(30 days)
Not Found
No
The summary describes image analysis software with automated tools and features like registration, segmentation, and reporting, but it does not explicitly mention AI, ML, or related concepts like deep learning or neural networks. The description focuses on traditional image processing and analysis techniques.
No
This device is an image analysis software package designed to support diagnostic oncology, staging, and follow-up, rather than providing or delivering therapy.
Yes.
The "Intended Use / Indications for Use" section states that "syngo CT Oncology is a self-contained, non invasive image analysis software package designed to support the physician in routine diagnostic oncology, staging and follow-up." The term "diagnostic oncology" directly indicates its use for diagnosis.
Yes
The device is described as a "self-contained, non invasive image analysis software package" and its function is solely focused on processing and analyzing medical images (CT and PET data). There is no mention of any accompanying hardware components that are part of the device itself.
Based on the provided information, 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 CT Oncology is an "image analysis software package" that processes "CT data" and "PET data". This involves analyzing medical images, not biological samples.
- Intended Use: The intended use is to "support the physician in routine diagnostic oncology, staging and follow-up" through image analysis and comparison. This is a function related to medical imaging interpretation, not in vitro testing.
Therefore, syngo CT Oncology falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
syngo CT Oncology is a self-contained, non invasive image analysis software package designed to support the physician in routine diagnostic oncology, staging and follow-up. Flexible layouts and automated image registration facilitate the synchronous display and navigation of multiple datasets for viewing multi-phase CT data and easy follow-up comparison. The application provides a range of interactive tools specifically designed for segmentation and volumetric analysis of lesions and includes dedicated tools to support the physician in lung, liver and lymph node assessment in CT data. Dedicated workflowsupport and integrated, accumulative reporting help to track lesions and their changes in e.g. size, shape and enhancement pattern over time. syngo CT Oncology also facilitates functional imaging offering fusion with other modalities such as PET data. It also features syngo LungCAD for detecting small lung nodules (PMA-approved).
Product codes
90 JAK
Device Description
syngo CT Oncology is a self-contained, non invasive image analysis software package designed to fast-track routine diagnostic oncology, staging and follow-up. Flexible layouts and automated image registration facilitate the synchronous display and navigation of multiple datasets for viewing multi-phase CT data and easy follow-up comparison. The application provides a range of automated tools specifically designed to support physicians in the segmentation and volumetric evaluation of suspicious lesions including dedicated tools for lung, liver and lymph node assessment in CT data. Dedicated workflow-support and integrated, accumulative reporting allow to track lesions and their changes in e.g. size, shape and enhancement pattern over time. syngo CT Oncology also facilitates functional imaging offering fusion with other modalities such as PET data. It also features syngo LungCAD for detecting small lung nodules (PMA-approved).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT data, PET data
Anatomical Site
lung, liver and lymph node
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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)
K022013, K061696, K963345, K010938
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Summary
K071310
JUN - 8 2007
SECTION 9
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
GENERAL INFORMATION l.
1. Device Name and Classification
syngo CT Oncology - Software Package Product Name: Classification Name: Accessory to Computed Tomography System Classification Panel: Radiology 21 CFR §892.1750 CFR Section: Device Class: Class II Product Code: 90 JAK
2. lmporter/Distributor Establishment:
Registration Number: 2240869
Siemens Medical Solutions, Inc. 51 Valley Stream Pkwy Malvern, PA 19355
Manufacturing Facility: 3.
Siemens AG Wittelsbacherplatz 2 D-80333 Muenchen, Germany
4. Contact Person:
Dr. Kristin Frowein Regulatory Submissions Specialist Siemensstr.1; D-91301 Forchheim +49 9191 18-9638 Phone: +49 9191 18-9782 Fax:
5. Date of Preparation of Summary: January 25, 2007
1
II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION
General Safety and Effectiveness Concerns 6.
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 hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.
7. Substantial Equivalence
The syngo CT Oncology software package that is addressed in this premarket notification, is substantially equivalent to the following commercially available software package:
| Manufacturer | Product | 510(k) | Clearance date |
|---|---|---|---|
| 1. Siemens AG | LungCARE CT | ||
| SW Package | K022013 | 07/16/2002 | |
| 2. Edda Technology, Inc. | IQQA-Liver | K061696 | 11/13/2006 |
| 3. GE Medical Systems | Advantage Windows | K963345 | |
| Tissue Volume Option | 10/18/1996 | ||
| 4. Siemens AG | syngo Multimodality | K010938 | 06/26/2001 |
| Workstation | |||
| (feature: Image Fusion) |
Device Description and Intended Use: 8.
syngo CT Oncology is a self-contained, non invasive image analysis software package designed to fast-track routine diagnostic oncology, staging and follow-up. Flexible layouts and automated image registration facilitate the synchronous display and navigation of multiple datasets for viewing multi-phase CT data and easy follow-up comparison. The application provides a range of automated tools specifically designed to support physicians in the segmentation and volumetric evaluation of suspicious lesions including dedicated tools for lung, liver and lymph node assessment in CT data. Dedicated workflow-support and integrated, accumulative reporting allow to track lesions and their changes in e.g. size, shape and enhancement pattern over time. syngo CT Oncology also facilitates functional imaging offering fusion with other modalities such as PET data. It also features syngo LungCAD for detecting small lung nodules (PMA-approved).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "HEALTH & HUMAN SERVICES - USA". The symbol in the center appears to be three stylized lines or curves, possibly representing a stylized bird or abstract design.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Siemens AG Medical Solutions % Mr. Stefan Preiss Responsible Third Party Official TÜV SÜD America, Inc. 1775 Old Highway 8 N.W., Suite 104 NEW BRIGHTON MN 55112-1891
Re: K071310
Trade/Device Name: syngo CT Oncology - Software Package Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: May 22, 2007 Received: May 25, 2007
Dear Mr. Preiss:
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.
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 regulations affecting 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/2/Picture/9 description: The image shows a circular logo with the text "1896-1996" at the top and "Centennial" at the bottom. In the center of the logo, there are the letters "PA" in a stylized font. Below the word "Centennial" are four stars arranged in a horizontal line. The logo appears to be a commemorative emblem for a centennial celebration.
noting Public Health
3
Page 2 -
Enclosure
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/cdrlvindustry/support/index.html.
Sincerely yours,
Nancy Cbrogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
SIEMENS
Indication for Use
SECTION 3
INDICATION FOR USE
510(k) Number (if known):
Device Name:
syngo CT Oncology - Software Package
Indications for Use:
syngo CT Oncology is a self-contained, non invasive image analysis software package designed to support the physician in routine diagnostic oncology, staging and follow-up. Flexible layouts and automated image registration facilitate the synchronous display and navigation of multiple datasets for viewing multi-phase CT data and easy follow-up comparison. The application provides a range of interactive tools specifically designed for segmentation and volumetric analysis of lesions and includes dedicated tools to support the physician in lung, liver and lymph node assessment in CT data. Dedicated workflowsupport and integrated, accumulative reporting help to track lesions and their changes in e.g. size, shape and enhancement pattern over time. syngo CT Oncology also facilitates functional imaging offering fusion with other modalities such as PET data. It also features syngo LungCAD for detecting small lung nodules (PMA-approved).
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | AN |
ND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
OF NEEDED)
concurrence of CDRH, Office of Device Evaluation (ODE)
Helstener
on Sign-Off Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number