DIGITAL RADIOGRAPHY MODEL CXDI-55G
FDA 510(k) clearance K091435 · decided 2009-05-29
Clearance details
- K-number
- K091435
- Device name
- DIGITAL RADIOGRAPHY MODEL CXDI-55G
- Applicant
- Canon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-05-14
- Decision date
- 2009-05-29
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- MQB
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Lake Success, NY, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CX recall (Z-2265-2012) | Canon Inc. | 2012-08-24 |