(85 days)
Not Found
Not Found
No
The summary describes a standard CT scanner with software for image reconstruction and management, but there is no mention of AI or ML capabilities.
No
The device is described as an X-ray computed tomography scanner that produces cross-sectional images of the body for diagnostic purposes (image reconstruction and evaluation), not for treating a disease or condition.
Yes
The device produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. This is a common function of diagnostic imaging devices used to visualize internal structures for medical diagnosis.
No
The device description explicitly states it is a "whole body X-ray computed tomography scanner," which is a hardware device. While it includes software for control and image processing, it is not solely software.
Based on the provided information, the SOMATOM Project 10 system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for producing cross-sectional images of the body using X-ray transmission data. This is a diagnostic imaging procedure performed on a living patient (in vivo), not a test performed on biological samples outside the body (in vitro).
- Device Description: The description confirms it's a whole body X-ray computed tomography scanner, which is an imaging device used directly on patients.
- No mention of biological samples: There is no indication that this device is used to analyze blood, urine, tissue, or any other biological sample.
IVD devices are specifically designed to perform tests on biological specimens to provide information for diagnosis, monitoring, or screening. The SOMATOM Project 10 is a medical imaging device used for visualizing internal structures of the body.
N/A
Intended Use / Indications for Use
The SOMATOM P10 systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes* taken at different angles. (*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)
Product codes
90 JAK
Device Description
The Siemens SOMATOM Project 10 systems are a whole body X-ray computed tomography scanners, which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image . . archive/evaluation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray transmission data
Anatomical Site
body
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Siemens SOMATOM Plus 4, General Electrics Hispeed (DX/i and LX/i) systems
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
SIEMENS
AUG 17 1999
.
Attachment 1
Summary of Safety and Effectiveness
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 I.
| Device Name: | SOMATOM Project 10 Computed Tomography X-ray
Systems |
|-----------------------|------------------------------------------------------------------------------|
| Classification Name: | & 892.1750:
Computed tomography X-ray system |
| Propriety Trade Name: | SOMATOM Star / SOMATOM Sprinter |
| Classification: | Class II |
| Performance Standard: | 21 CFR Subchapter J,
Federal Diagnostic X-ray Equipment Standard |
| Registration Number: | 2240869 |
| Address: | Siemens Medical Systems, Inc.
186 Wood Avenue South
Iselin, N.J. 08830 |
| Contact Person: | Kathleen M. Rutherford
Manager, Regulatory Submissions
(732) 321-4779 |
Date of Summary Preparation: 5/20/99
1
II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination
Device Description:
The Siemens SOMATOM Project 10 systems are a whole body X-ray computed tomography scanners, which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image . . archive/evaluation.
Intended Use:
The SOMATOM P10 systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes* taken at different angles.
(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)
Technological Characteristics:
The SOMATOM Project 10 systems are whole body X-ray computed tomography scanners, which features a continuously rotating tube-detector system and functions according to the fan beam principle. The systems are based on the existing SOMATOM Plus 4 system (for further details see chapter 2). The system will operate with SOMARIS/4.5 software.
General Safety and Effectiveness Concerns:
All components of the SOMATOM Project 10 systems subject to the Federal Diagnostic Equipment Performance Standard and applicable regulations of 21CFR § 1020.30 and § 1020.33 are certified to meet those requirements; and an initial report as per 21 CFR § 1002.10 will be filed with the Center for Devices and Radiological Health (CDRH). To minimize electrical, mechanical, and radiation hazards. Siemens adheres to recognized and established industry The SOMATOM is designed to meet the ELECTRICAL AND MECHANICAL practice. SAFETY STANDARD IEC 601-1 and UL 187 X-RAY EQUIPMENT STANDARD FOR SAFETY.
Substantial Equivalence:
The SOMATOM Project 10 systems operating with SOMARIS/4.5 software are substantially equivalent to the Siemens SOMATOM Plus 4 and General Electrics Hispeed (DX/i and LX/i) systems in commercial distribution.
Kattlen Rutherford
Kathleen Rutherford Manager, Regulatory Submissions
5/21/99
Date
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 7 1999
Alicia Juergensen Technical Specialist Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830
RE:
K991764 Somatom Project 10-CT Scanners Dated: May 20, 1999 Received: May 24, 1999 Regulatory Class: II 21 CFR 892.1750/Procode: 90 JAK
Dear Ms. Juergensen:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 redassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act). 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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".
Sincerely yours,
[signature]
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Attachment 2
Indication for use
510(k) Number (if known):
Device Name:
SOMATOM Project 10 systems
Indication for use:
The SOMATOM Project 10 systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes* taken at different angles.
(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)
Daniel A. Szymon
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number
Prescription Use
(Per 21 CFR 801.109)