PRECISION RXI ANALOG X-RAY SYSTEM
FDA 510(k) clearance K041605 · decided 2004-06-30
Clearance details
- K-number
- K041605
- Device name
- PRECISION RXI ANALOG X-RAY SYSTEM
- Applicant
- General Medical Merate S.P.A
- Decision
- Substantially Equivalent
- Date received
- 2004-06-15
- Decision date
- 2004-06-30
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- OWB
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Seriate (Bg), IT
- Third-party review
- Yes
- Expedited review
- No
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