SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC
FDA 510(k) clearance K141563 · decided 2014-07-16
Clearance details
- K-number
- K141563
- Device name
- SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC
- Applicant
- Rayence Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2014-06-12
- Decision date
- 2014-07-16
- Days to decision
- 34 days
- Clearance type
- Special
- Product code
- MQB
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.