(76 days)
No
The summary does not mention AI, ML, or related concepts, and the device description focuses on standard CT technology.
No.
The SOMATOM Plus 4 CT Scanner is described as an imaging device that produces cross-sectional images of the body using X-ray transmission data for diagnostic purposes, not for treating diseases or conditions.
Yes
Explanation: The device produces cross-sectional images of the body using X-ray transmission data, which are then used by healthcare professionals to diagnose medical conditions. This function aligns with the definition of a diagnostic device.
No
The device description explicitly states it is a "whole body computed tomography X-ray scanner," which is a hardware device. While it includes software (Somaris 4/B30), the core device is a physical scanner.
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 crosssectional 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 for testing samples in vitro (outside the body).
- Device Description: The description confirms it's a "whole body computed tomography X-ray scanner". This is consistent with an imaging device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the SOMATOM Plus 4 CT Scanner is a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The SOMATOM Plus 4 CT Scanner is intended to produce crosssectional images of the body by computer reconstruction of X-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles. * The axial planes resulted from the continuous rotation of detectors and X-ray tube and the simultaneous translation of the patient.
Product codes
90IAK
Device Description
The SOMATOM Plus 4 with Somaris 4/B30 software is a whole body computed tomography X-ray scanner, which features a continuously rotating tube-detector system and functions according to the fan beam principle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
whole 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
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
Image /page/0/Picture/0 description: The image shows the word "SIEMENS" in bold, black letters. The letters are large and evenly spaced, filling most of the frame. The font appears to be sans-serif, and the overall impression is one of clarity and prominence.
FEB 1 0 1997 Attachment 12
510(k) Summary
Siemens SOMATOM Plus 4 Computed Tomography (CT) Scanner with Somaris 4/B30 Software
Submitted by:
Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830
November 25, 1996
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR $807.92.
Contact Person: 1.
Ms. Jing Zhang Phone: (908)321-4927 Fax: (908)321-4841
Device Name and Classification: 2.
Trade Name: Classification Name: Classification Panel: CFR Section: Device Class: Device Code:
SOMATOM Plus 4 CT Scanner Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II 90IAK
3. Intended Use:
The SOMATOM Plus 4 CT Scanner is intended to produce crosssectional images of the body by computer reconstruction of X-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.
- The axial planes resulted from the continuous rotation of detectors and X-ray tube and the simultaneous translation of the patient.
1
SIEMENS
র. Substantial Equivalence:
The new SOMATOM Plus 4 CT Scanner is substantially equivalent to the following devices in commercial distribution:
5. Device Description:
The SOMATOM Plus 4 with Somaris 4/B30 software is a whole body computed tomography X-ray scanner, which features a continuously rotating tube-detector system and functions according to the fan beam principle.
6. Summary of Technological Characteristics of the Device Compared to the Predicate Device:
The SOMATOM Plus 4 operating with Somaris 4/B30 software has the same technological characteristics as the predicate Plus 4 operating with Somaris 4/B20 software, except the addition of an optional solid state detector. The change from xenon detector to solid state detector does not change the overall design and operation of the Plus 4 scanner. Since the solid state detector has a higher conversion efficiency, the low contrast resolution is improved and the image noise is reduced.
Kathleen Rutherford
Kathleen Rutherford
Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc.