QUIX DIGITAL RADIOGRAPHIC UPGRADE
FDA 510(k) clearance K052661 · decided 2006-06-07
Clearance details
- K-number
- K052661
- Device name
- QUIX DIGITAL RADIOGRAPHIC UPGRADE
- Applicant
- Edge Medical Devices , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-27
- Decision date
- 2006-06-07
- Days to decision
- 253 days
- Clearance type
- Traditional
- Product code
- MQB
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Raanana, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.