FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A
K Number: K960948
·
Decision Dec 23, 1996
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
470
Applicant Total
54
Review Days
290
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Basic Information
- Device Name
- SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A
- K Number
- K960948
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1200
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Toshiba Medical Systems
- Date Received
- March 8, 1996
- Decision Date
- December 23, 1996
- Product Code
- KPS
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | FDA class 2 | Radiology |
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Other Clearances by Toshiba Medical Systems
| K Number | Device Name | ||
|---|---|---|---|
| K954310 | BLA-800A | Oct 18, 1995 | Substantially Equivalent |
| K954309 | ANGIOREX | Oct 6, 1995 | Substantially Equivalent |
| K893750 | MRT-50A MOBILE | Aug 9, 1989 | Substantially Equivalent |
| K891453 | DIAGNOSTIC ULTRASOUND TRANSDUCER: PVE-582V | Jun 1, 1989 | Substantially Equivalent |
| K890969 | TRANSESOPHAGEAL TRANSDUCER PEF-511SA | May 16, 1989 | Substantially Equivalent |
| K884555 | TCT-600HQ COMPU TOMO(CT)XRAY/HEAD/WHOLE BODY EXAM | Feb 27, 1989 | Substantially Equivalent |
| K884788 | TOSHIBA TCT-600XT COMPUTED TOMOGRAPHY X-RAY SYSTEM | Feb 27, 1989 | Substantially Equivalent |
| K883359 | DIAGNOSTIC ULTRASOUND SYSTEM SSA-270A | Jan 25, 1989 | Substantially Equivalent |
| K883756 | TOSHIBA MRT-50A MAGNETIC RESONANCE SYSTEM | Nov 14, 1988 | Substantially Equivalent |
| K881305 | TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM | Oct 19, 1988 | Substantially Equivalent |