HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
FDA 510(k) clearance K052434 · decided 2005-09-27
Clearance details
- K-number
- K052434
- Device name
- HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
- Applicant
- GE Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2005-09-06
- Decision date
- 2005-09-27
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Tirat Hacarmel, IL
- Third-party review
- No
- Expedited review
- No
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