K964747 · Siemens Medical Solutions USA, Inc. · JAK · Feb 10, 1997 · Radiology
Device Facts
Record ID
K964747
Device Name
SOMATOM PLUS 4 CT SCANNER
Applicant
Siemens Medical Solutions USA, Inc.
Product Code
JAK · Radiology
Decision Date
Feb 10, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.1750
Device Class
Class 2
Indications for Use
The SOMATOM Plus 4 CT Scanner 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 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.
Device Story
Whole body CT scanner; utilizes continuously rotating tube-detector system; operates on fan beam principle. Inputs: X-ray transmission data. Processing: computer reconstruction of data from multiple angles (axial or spiral). Output: cross-sectional body images. Used in clinical radiology settings; operated by trained radiologic technologists/physicians. Output used by clinicians for diagnostic visualization and clinical decision-making. Benefits: improved low contrast resolution and reduced image noise via solid state detector technology.
Clinical Evidence
Bench testing only. No clinical data provided. Equivalence established through technical comparison of detector performance (conversion efficiency, resolution, noise reduction).
Technological Characteristics
Whole body CT X-ray system; fan beam geometry; continuously rotating tube-detector gantry. Features optional solid state detector (replacing xenon detector). Software: Somaris 4/B30. Connectivity: standard CT imaging system architecture.
Indications for Use
Indicated for patients requiring cross-sectional body imaging via computed tomography X-ray reconstruction.
Regulatory Classification
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.
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SIEMENS
FEB 10 1997
K964747
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.
1. Contact Person:
Ms. Jing Zhang
Phone: (908)321-4927 Fax: (908)321-4841
2. Device Name and Classification:
Trade Name: SOMATOM Plus 4 CT Scanner
Classification Name: Computed Tomography X-ray System
Classification Panel: Radiology
CFR Section: 21 CFR §892.1750
Device Class: Class II
Device Code: 90JAK
3. Intended Use:
The SOMATOM Plus 4 CT Scanner 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
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.
Simplified 510(k) for modified SOMATOM Plus 4 Siemens Medical Systems, Inc. Pg. 28 of 31
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Simplified 510(k) for modified SOMATOM Plus 4 Siemens Medical Systems, Inc. Pg. 29 of 31
# SIEMENS
## 4. Substantial Equivalence:
The new SOMATOM Plus 4 CT Scanner is substantially equivalent to the following devices in commercial distribution:
- SOMATOM Plus 4 CT Scanner, K941546
Siemens Medical Systems, Inc.
- HiSpeed Advantage, K940606
GE
## 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
Manager, Regulatory Submissions
Siemens Medical Systems, Inc.
