IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM— 510(k) K963395
Substantially EquivalentSectra-Imtec AB
FDA 510(k) clearance K963395 for IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM, Substantially Equivalent on 1996-10-25. Applicant: Sectra-Imtec AB. Device class: 1.
Clearance details
- Applicant
- Sectra-Imtec AB
- Product code
- Code LMB
- Device class
- Class 1
- Regulation
- 21 CFR 892.2010
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plano, TX, US
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