ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL— 510(k) K974423
Substantially EquivalentSterling Diagnostic Imaging, Inc.
FDA 510(k) clearance K974423 for ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL, Substantially Equivalent on 1997-12-22. Applicant: Sterling Diagnostic Imaging, Inc.. Device class: 1.
Clearance details
- Applicant
- Sterling Diagnostic Imaging, Inc.
- Product code
- Code EAM
- Device class
- Class 1
- Regulation
- 21 CFR 892.1960
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Greenville, SC, US
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