(30 days)
Not Found
No
The summary describes a standard CT scanner with a mechanical innovation (sliding gantry) and does not mention any AI/ML components or image processing capabilities beyond basic reconstruction.
No
Explanation: The device is described as an X-ray computed tomography scanner intended to produce cross-sectional images of the body for diagnostic purposes, not for treating diseases or conditions.
Yes
Explanation: The device is described as an X-ray computed tomography scanner that produces cross-sectional images of the body for reconstruction. The ability to generate images of the body for reconstruction indicates its use as a tool for diagnosing medical conditions.
No
The device description clearly states it is a whole body X-ray computed tomography scanner, which is a hardware device. The "Sliding Gantry Option" is also a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to produce cross-sectional images of the body using X-ray transmission data. This is a diagnostic imaging device, not a device used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description confirms it's a whole body X-ray computed tomography scanner. This is consistent with an imaging device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the SOMATOM Plus 4 with Sliding Gantry Option is a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The SOMATOM Plus 4 with Sliding Gantry Option is 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 movement of the sliding gantry).
Product codes
90 JAK
Device Description
The SOMATOM Plus 4 with Sliding Gantry Option is a whole body X-ray computed tomography scanner that features a continuously rotating tube-detector system and functions according to the fan beam principle. The Sliding Gantry Option integrates the function of precise scan control driven horizontal movement, which is usually a function of the dedicated CT-table, into the CT gantry itself. This is achieved by mounting the gantry on a dedicated rail system and by having a scan control system that moves the gantry relative to the table instead of moving the table relative to the gantry.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 892.1750 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
9 1999 JUN
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.
I. General Information
| Device Name: | SOMATOM Plus 4 with Sliding Gantry Option |
|---|---|
| Classification Name: | § 892.1750: |
| Computed tomography X-ray system | |
| Propriety Trade Name: | SOMATOM Plus 4 with Sliding Gantry Option |
| Classification: | Class II |
| Performance Standards: | 21 CFR Subchapter J, Federal |
| Diagnostic X-ray Equipment Standard | |
| Establishment Regist. Number: | 2240869 |
| Address: | Siemens Medical Systems, Inc. |
| 186 Wood Avenue South | |
| Iselin, NJ 08830 | |
| Contact Person: | Kathleen M. Rutherford |
| Manager, Regulatory Submissions | |
| (732) 321-4779 |
1
II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination
Device Description:
The SOMATOM Plus 4 with Sliding Gantry Option is a whole body X-ray computed tomography scanner that features a continuously rotating tube-detector system and functions according to the fan beam principle. The Sliding Gantry Option integrates the function of precise scan control driven horizontal movement, which is usually a function of the dedicated CT-table, into the CT gantry itself. This is achieved by mounting the gantry on a dedicated rail system and by having a scan control system that moves the gantry relative to the table instead of moving the table relative to the gantry.
Intended Use:
The SOMATOM Plus 4 with Sliding Gantry Option is 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 movement of the sliding gantry).
Technological Characteristics:
The SOMATOM Plus 4 with Sliding Gantry Option is a whole body X-ray computed tomography scanner that features a continuously rotating tube-detector system and functions according to the fan beam principle. The system is based on the existing SOMATOM PLUS 4 system. The Sliding Gantry functionality will be marketed as an optional package for the existing SOMATOM Plus 4 system and will also be offered as an upgrade to already installed systems. The system operates with SOMARIS/4 software.
General Safety and Effectiveness Concerns:
The SOMATOM Plus 4 CT Sliding Gantry 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 has been filed at the Center for Devices and Radiological Health (CDRH) (Reference no. 9412312-06 on March 25, 1999). To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice. The SOMATOM Plus 4 CT Sliding Gantry is designed to meet the ELECTRICAL AND MECHANICAL SAFETY STANDARD IEC 601-1 and UL 187 X-RAY EQUIPMENT STANDARD FOR SAFETY.
Substantial Equivalence:
The SOMATOM Plus 4 CT Sliding Gantry Option is substantially equivalent to the Angio-CT MIYABI (described in K990491 cleared April 5, 1999) and SOMATOM Project 059 (described in K941546 cleared September 10, 1994) in commercial distribution.
Ketles Rutherford 5/7/99
Signature Date
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" written around the edge. Inside the circle is a stylized image of an eagle. The eagle is depicted with its wings spread, and its head is turned to the left.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
d 1899 JUN
Alicia Bustos-Juergensen Technical Specialist Siemens Corporation 186 Wood Avenue South Iselin, New Jersey 08830 Re:
K991600 SOMATOM Plus 4 with Sliding Gantry Option CT System Dated: May 7, 1999 Received: May 10, 1999 Regulatory Class: II 21 CFR 892.1750/Procode: 90 JAK
Dear Ms. Bustos-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 requlation 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,
Dan Letizia
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
SIEMENS
Attachment 2
Indication for use
Device Name:
510(k) Number (if known):
Sliding Gantry Option
Indication for use:
The SOMATOM Plus 4 with Sliding Gantry Option is 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 movement of the sliding gantry.)
Ra-Q. Pacey
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number _
Prescription Use
(Per 21 CFR 801.109) ✓