SIS 2000 MAMMOGRAPHIC X-RAY SYSTEM— 510(k) K885127
Substantially EquivalentFischer Imaging Corp.
FDA 510(k) clearance K885127 for SIS 2000 MAMMOGRAPHIC X-RAY SYSTEM, Substantially Equivalent on 1989-02-16. Applicant: Fischer Imaging Corp.. Device class: 2.
Clearance details
- Applicant
- Fischer Imaging Corp.
- Product code
- Code LMC
- Device class
- Class 2
- Regulation
- 21 CFR 892.2040
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Denver, CO, US
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