The following data is part of a premarket notification filed by Liebel-flarsheim with the FDA for Liebel-flarsheim Direct Digital Imaging System.
| Device ID | K121838 |
| 510k Number | K121838 |
| Device Name: | LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | LIEBEL-FLARSHEIM 2111 EAST GALBRAITH RD Cincinnati, OH 45237 |
| Contact | Craig Buehler |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-06-22 |
| Decision Date | 2012-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10746190002826 | K121838 | 000 |
| 10746190002819 | K121838 | 000 |
| 10746190002475 | K121838 | 000 |
| 10746190002468 | K121838 | 000 |