DIGITAL X-RAY IMAGING SYSTEM
FDA 510(k) clearance K111103 · decided 2012-01-05
Clearance details
- K-number
- K111103
- Device name
- DIGITAL X-RAY IMAGING SYSTEM
- Applicant
- Rf Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-04-20
- Decision date
- 2012-01-05
- Days to decision
- 260 days
- Clearance type
- Traditional
- Product code
- MUH
- Device class
- 2
- Regulation number
- 872.1800
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Bunkyo-Ku, Tokyo, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.