FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRISPICS
K Number: K954211
·
Decision Dec 5, 1995
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
8
Review Days
89
Basic Information
- Device Name
- CRISPICS
- K Number
- K954211
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MERLIN ENGINEERING WORKS, INC.
- Date Received
- September 7, 1995
- Decision Date
- December 5, 1995
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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Other Clearances by MERLIN ENGINEERING WORKS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K974882 | DOWNSCAN LT | May 22, 1998 | Substantially Equivalent |
| K971154 | MULTIPICS(ME-977) | Jun 25, 1997 | Substantially Equivalent |
| K971153 | SPLITSCREEN (ME-975) | Jun 25, 1997 | Substantially Equivalent |
| K970451 | DOWNSCAN 120 | Apr 7, 1997 | Substantially Equivalent |
| K970450 | UPSCAN 120 | Apr 1, 1997 | Substantially Equivalent |
| K953398 | UNISCAN | Oct 6, 1995 | Substantially Equivalent |
| K933512 | UPSCAN | Apr 19, 1995 | Substantially Equivalent |