SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW— 510(k) K013897
Substantially EquivalentBio-Scan S.A
FDA 510(k) clearance K013897 for SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW, Substantially Equivalent on 2002-05-21. Applicant: Bio-Scan S.A. Device class: 2.
Clearance details
- Applicant
- Bio-Scan S.A
- Product code
- Code MQB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Stamford, CT, US
Recent devices under product code MQB
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