LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM
FDA 510(k) clearance K121838 · decided 2012-07-11
Clearance details
- K-number
- K121838
- Device name
- LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM
- Applicant
- Liebel-Flarsheim
- Decision
- Substantially Equivalent
- Date received
- 2012-06-22
- Decision date
- 2012-07-11
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- MQB
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Cincinnati, OH, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.