FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL
K Number: K974423
·
Decision Dec 22, 1997
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
34
Applicant Total
7
Review Days
28
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Basic Information
- Device Name
- ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL
- K Number
- K974423
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1960
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sterling Diagnostic Imaging, Inc.
- Date Received
- November 24, 1997
- Decision Date
- December 22, 1997
- Product Code
- EAM
- 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 |
|---|---|---|---|
| EAM | Screen, Intensifying, Radiographic | FDA class 1 | Radiology |
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Other Clearances by Sterling Diagnostic Imaging, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K980970 | IIRAD DIRECTRAY OPERATOR CONSOLE | Jun 8, 1998 | Substantially Equivalent |
| K980220 | IISYS PACS SYSTEM | Feb 13, 1998 | Substantially Equivalent |
| K973206 | STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY | Dec 4, 1997 | Substantially Equivalent |
| K972660 | RAVEN DRY PRINTER | Nov 10, 1997 | Substantially Equivalent |
| K973028 | HELIOS LASER IMAGER 1417 | Oct 28, 1997 | Substantially Equivalent |
| K964250 | LINX NETWORKING SYSTEM | Dec 18, 1996 | Substantially Equivalent |