FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANGIOREX
K Number: K954309
·
Decision Oct 6, 1995
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
198
Applicant Total
54
Review Days
21
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Basic Information
- Device Name
- ANGIOREX
- K Number
- K954309
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1600
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Toshiba Medical Systems
- Date Received
- September 15, 1995
- Decision Date
- October 6, 1995
- Product Code
- IZI
- 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 |
|---|---|---|---|
| IZI | System, X-Ray, Angiographic | FDA class 2 | Radiology |
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|---|---|---|---|
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| 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 |