(85 days)
The C.A.R.E. VISION is intended to be used for instant display of CT images during interventional procedures using CT scanners. Instant image reconstruction of 3-9 images per second allows the physician to watch the placement of an interventional instrument real time.
The C.A.R.E. VISION option is a new scan mode added to the SOMATOM Plus 4 CT scanner. The option can be installed in the SOMATOM Plus 4 CT as an upgrade kit consisting of hardware, software and firmware. Under C.A.R.E. VISION, three to nine images are reconstructed and displayed per second, effectively simulating a real-time display presentation. More than one C.A.R.E. VISION scans can be set-up and performed one after the other. C.A.R.E. VISION can also be mixed with other scan modes. Switch to SEQUENCE scan mode can be initiated any time during C.A.R.E. VISION thus a particular phase of the operation can be displayed in enhanced image quality.
This document does not contain the information required to answer the request regarding acceptance criteria and device performance. The provided text is a 510(k) summary for the C.A.R.E. VISION Option for SOMATOM Plus 4 CT System, primarily focusing on its description, intended use, and substantial equivalence to predicate devices. It does not include:
- A table of acceptance criteria and reported device performance.
- Details about a test set, its sample size, or data provenance.
- Information on experts or ground truth establishment for a test set.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- The type of ground truth used.
- Training set sample size or ground truth establishment for a training set.
The document discusses the device's ability to reconstruct and display 3-9 images per second, effectively simulating real-time, and its use during interventional procedures to guide instrument placement. However, it does not provide quantitative performance metrics or studies to prove acceptance criteria.
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MAR 1 1 1997
Appendix 1
510(k) Summary C.A.R.E. VISION Option for SOMATOM Plus 4 CT System
Submitted by:
Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830
December 13, 1996
This 510(k) summary of safety and effectiveness information is being This 510(K) summary of Safety and Check. Sheet Pontos and 21 CFR $807.92.
- Contact Person: 1.
Ms. Jing Zhang Fax: (908)321-4841 Phone: (908)321-4927
Device Name and Classification: 2.
| Trade Name: | C.A.R.E. VISION for the SOMATOM Plus 4 CT |
|---|---|
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750, Class II |
| Device Code: | 90JAK |
Substantial Equivalence: 3.
Substantial Equivalence.
The C.A.R.E. VISION option operating on SOMATOM Plus 4 CT The C.A.K.B. VIDION of equivalent to the following devices:
- SOMATOM Plus 4 CT 1) Siemens Medical Systems, Inc., for scanning
- Real Time Reconstruction System Option for Xpress/SX CT 2) System Toshiba America Medical Systems, Inc. for real time image reconstruction and display
Device Description: 4.
Device Description...
The C.A.R.E. VISION option is a new scan mode added to the The C.A.R.E. VIDEON openner. The option can be installed in the SOMATOM Flus I C1 bean upgrade kit consisting of hardware, software and firmware.
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SIEMENS
Under C.A.R.E. VISION, three to nine images are reconstructed and displayed per second, effectively simulating a real-time display presentation. More than one C.A.R.E. VISION scans can be set-up and performed one after the other. C.A.R.E. VISION can also be mixed with other scan modes. Switch to SEQUENCE scan mode can be initiated any time during C.A.R.E. VISION thus a particular phase of the operation can be displayed in enhanced image quality.
Intended Use of the Device: 5.
The C.A.R.E. VISION is intended to be used for instant display of CT images during interventional procedures using CT scanners. Instant image reconstruction of 3-9 images per second allows the physician to watch the placement of an interventional instrument real time.
- Summary of Technological Characteristics of the Device Compared to 6. the Predicate Device:
The C.A.R.E. Vision has the same technological characteristics as the Real Time Reconstruction System Option for Xpress/SX CT System from Toshiba America Medical Systems, Inc. They both provide real time reconstruction and display of the CT images that can be used in conventional interventional CT exams.
Kathleen Rutherford
Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc.
§ 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.