FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JAMIESON JT-CRP CINE FILM PROCESSOR
K Number: K913241
·
Decision Sep 24, 1991
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
5
Applicant Total
6
Review Days
64
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Basic Information
- Device Name
- JAMIESON JT-CRP CINE FILM PROCESSOR
- K Number
- K913241
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1900
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Jamieson Film Co.
- Date Received
- July 22, 1991
- Decision Date
- September 24, 1991
- Product Code
- IXX
- 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 |
|---|---|---|---|
| IXX | Processor, Cine Film | FDA class 2 | Radiology |
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Other Clearances by Jamieson Film Co.
| K Number | Device Name | ||
|---|---|---|---|
| K970738 | KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT | May 7, 1997 | Substantially Equivalent |
| K971128 | CAP-35B III/CINE 275 | Apr 28, 1997 | Substantially Equivalent |
| K963334 | JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100 | Sep 11, 1996 | Substantially Equivalent |
| K960043 | KODAK CARDIOLOGY DIGITAL ARCHIVE & REVIEW SYSTEM | Mar 27, 1996 | Substantially Equivalent |
| K953563 | VANGUARD XR-350 CINEANGIOGRAM PROJECTOR | Oct 5, 1995 | Substantially Equivalent |