FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CEMAX SCANLINK V
K Number: K943357
·
Decision Nov 22, 1994
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
60
Applicant Total
7
Review Days
133
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Basic Information
- Device Name
- CEMAX SCANLINK V
- K Number
- K943357
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2030
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cemax, Inc.
- Date Received
- July 12, 1994
- Decision Date
- November 22, 1994
- Product Code
- LMA
- 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 |
|---|---|---|---|
| LMA | Digitizer, Image, 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 |
| 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 |
| K905801 | CEMAX SPARCSTATION IMAGING SOFTWARE AND WORKSTATIO | Mar 22, 1991 | Substantially Equivalent |
| K880169 | CEMAX 5000 MULTIDIMENSIONAL IMAGING WORKSTATION | Mar 9, 1988 | Substantially Equivalent |