DISCOVERY MODEL NM/CT 670
FDA 510(k) clearance K093514 · decided 2009-12-10
Clearance details
- K-number
- K093514
- Device name
- DISCOVERY MODEL NM/CT 670
- Applicant
- Ge Medical Systems F.I. Haifa
- Decision
- Substantially Equivalent
- Date received
- 2009-11-13
- Decision date
- 2009-12-10
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Tirat Hacarmel, IL
- Third-party review
- Yes
- Expedited review
- No
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