EXPEDIO 500D R&F X-RAY SYSTEM
FDA 510(k) clearance K011624 · decided 2001-06-08
Clearance details
- K-number
- K011624
- Device name
- EXPEDIO 500D R&F X-RAY SYSTEM
- Applicant
- GE Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2001-05-25
- Decision date
- 2001-06-08
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- JAA
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Waukesha, WI, US
- Third-party review
- Yes
- Expedited review
- No
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