(85 days)
Siemens Medical Systems, Inc., SOMATOM Plus 4 CT, Toshiba America Medical Systems, Inc., Real Time Reconstruction System Option for Xpress/SX CT System
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No
The description focuses on rapid image reconstruction and display for real-time visualization, not on AI/ML-driven analysis or interpretation. There is no mention of AI, ML, training data, or performance metrics typically associated with AI/ML devices.
No
The device aids in image display for interventional procedures, allowing real-time visualization of instrument placement, but it does not directly treat or prevent a disease or condition.
Yes
The device is described as allowing the physician to watch the placement of an interventional instrument in real-time, indicating its use in guiding medical procedures, which falls under diagnostic or procedural guidance rather than treatment or prevention.
No
The device description explicitly states that the C.A.R.E. VISION option is an upgrade kit consisting of hardware, software, and firmware, indicating it is not solely software.
Based on the provided information, the C.A.R.E. VISION device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- C.A.R.E. VISION Function: The C.A.R.E. VISION is a scan mode for a CT scanner. It processes and displays medical images (CT scans) taken of the body, not from the body. Its purpose is to aid in real-time visualization during interventional procedures, which is an in-vivo application.
The device's function is entirely focused on image acquisition, reconstruction, and display for direct visualization of internal structures and instrument placement within the patient's body. This falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
90JAK
Device Description
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 scanner 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
CT
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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)
Siemens Medical Systems, Inc., SOMATOM Plus 4 CT; Toshiba America Medical Systems, Inc., Real Time Reconstruction System Option for Xpress/SX CT System
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.
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Image /page/0/Picture/0 description: The image shows the word "SIEMENS" in bold, black letters. The letters are large and take up most of the frame. The font is sans-serif and appears to be a standard typeface. The background is white, providing a strong contrast with the black letters.
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.
1
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.