ADVANTAGE 3D XR
FDA 510(k) clearance K974715 · decided 1998-07-06
Clearance details
- K-number
- K974715
- Device name
- ADVANTAGE 3D XR
- Applicant
- GE Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 1997-12-17
- Decision date
- 1998-07-06
- Days to decision
- 201 days
- Clearance type
- Traditional
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Milwaukee, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.