FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMAGEMASTER-101(TM)
K Number: K897000
·
Decision Mar 23, 1990
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
7
Review Days
95
Basic Information
- Device Name
- IMAGEMASTER-101(TM)
- K Number
- K897000
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- COLUMBIA SCIENTIFIC, INC.
- Date Received
- December 18, 1989
- Decision Date
- March 23, 1990
- 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 COLUMBIA SCIENTIFIC, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K011180 | CT/MASTER, VERSION 1.0 | Jun 27, 2001 | Substantially Equivalent |
| K924810 | SIM/PLANT | Jan 15, 1993 | Substantially Equivalent |
| K885322 | 3D/DENTAL | Feb 9, 1989 | Substantially Equivalent |
| K880404 | CSI/QCT | Nov 17, 1988 | Substantially Equivalent |
| K870513 | CSI/3D | May 8, 1987 | Substantially Equivalent |
| K861852 | CSI/MPR OR CSI/MPR PLUS | Oct 8, 1986 | Substantially Equivalent |