(86 days)
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No
The summary describes a standard CT scanner with software for image reconstruction and management, without mentioning any AI/ML capabilities.
No.
The device is an imaging system (CT scanner) used for diagnostic purposes (producing images of the body), not for treating conditions.
Yes
The device produces cross-sectional images of the body, which are then used for image reconstruction and evaluation. This process of creating images to aid in the assessment of a medical condition aligns with the definition of a diagnostic device.
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, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "produce cross-sectional images of the body by computer reconstruction of x-ray transmission data". This describes an imaging device used for diagnostic purposes on the patient's body, not on samples taken from the patient's body.
- Device Description: The description confirms it's a "whole body X-ray computed tomography scanner". This is a type of medical imaging equipment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In vitro diagnostics are tests performed on samples taken from the human body to provide information about a person's health. This device is used for imaging the body directly.
N/A
Intended Use / Indications for Use
The SOMATOM Plus 4 with Volume Zoom package is used for whole body X-ray computed imaging.
The Somatom Plus 4 with Volume Zoom package 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 translation of the patient.)
Product codes (comma separated list FDA assigned to the subject device)
90 JAK
Device Description
The Siemens Somatom Plus 4 with Volume Zoom package is a whole body X-ray computed tomography scanner 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray
Anatomical Site
whole body
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
IEMENS
SEP 3 0 1998
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: Somatom Plus 4 with Volume Zoom package Trade Name: Common Name: CT Scanner Classification Name: § 892.1750: Computed tomography X-ray system Class II Classification: Performance Standard:21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard Establishment: Siemens Medical Systems, Inc. Address: 186 Wood Avenue South Iselin, N.J. 08830 Registration Number: 2240869 Contact Person: Kathleen M. Rutherford Manager, Regulatory Submissions (732) 321-4779 Date of Summary Preparation: 6/29/98
1
SIEMEN
II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination
Device Description:
The Siemens Somatom Plus 4 with Volume Zoom package is a whole body X-ray computed tomography scanner 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 Plus 4 with Volume Zoom package is used for whole body X-ray computed imaging.
Technological Characteristics:
The SOMATOM Plus 4 with Volume Zoom package is a whole body X-ray computed tomography scanner, which 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 (for further details see section 3). The Volume Zoom 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 with SOMARIS/5 software.
General Safety and Effectiveness Concerns:
All components of the Somatom Plus 4 with Volume Zoom package subject to the Federal Diagnostic Equipment Performance Standard and applicable regulations of 21CFR $ 1020.30 and § 1020.33 will 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). The SOMATOM is designed to meet the ELECTRICAL AND MECHANICAL SAFETY STANDARD IEC 601-1, +A1:1991, +A2:1995, and IEC 60601-1-2.
Substantial Equivalence:
The Somatom Plus 4 with Volume Zoom package operating with SOMARIS/5 software is substantially equivalent to the Siemens SOMATOM Plus 4, GE CT/I, Elscint Twin Flash and SOMATOM Plus 4 Power systems in commercial distribution.
Kathleen Rutherford
Manager, Regulatory Submissions
7/1/98
Date
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 3 0 1998
Alicia Juergensen Technical Specialist Siemens Medical Systems, Inc. 186 Wood Ave. South Iselin, NJ 08830
Re:
Somatom Plus 4 with Volume Zoom CT Scanners June 29, 1998 Dated: Received: July 6, 1998 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK
Dear Ms. Juergensen:
We have reviewed your Section 510%) 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 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). You may, therefore, market the device, subject to the general controls provisions of 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 895. A substantially equivalience with the Current Good Manufacturing Practice requirements, as set forth in the Ouality System Regulation (OS) 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 vour 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/dsmaldsmam.html".
Sincerely yours,
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa 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 Plus 4 with Volume Zoom package
Indication for use:
The Somatom Plus 4 with Volume Zoom package 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 translation of the patient.)
Caml l. Segon
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
cription Use 1 CFR 801.109)