FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CEMAX SPARCSTATION IMAGING SOFTWARE AND WORKSTATIO
K Number: K905801
·
Decision Mar 22, 1991
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
7
Review Days
84
Basic Information
- Device Name
- CEMAX SPARCSTATION IMAGING SOFTWARE AND WORKSTATIO
- K Number
- K905801
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- CEMAX, INC.
- Date Received
- December 28, 1990
- Decision Date
- March 22, 1991
- 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 CEMAX, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K950513 | ARCHIVEMANAGER | Nov 13, 1995 | Substantially Equivalent |
| K945188 | CEMAX VIPSTATION AND/OR SOFTWARE | Aug 2, 1995 | Substantially Equivalent |
| K943357 | CEMAX SCANLINK V | Nov 22, 1994 | Substantially Equivalent |
| K932371 | CEMAX CLINICALVIEW(TM) STATION AND/OR SOFTWARE | Feb 18, 1994 | Substantially Equivalent |
| K932372 | CEMAX VIPSTATION(TM) AND/OR SOFTWARE | Nov 22, 1993 | Substantially Equivalent |
| K880169 | CEMAX 5000 MULTIDIMENSIONAL IMAGING WORKSTATION | Mar 9, 1988 | Substantially Equivalent |