The following data is part of a premarket notification filed by Agfa Healthcare N.v. with the FDA for Cr 10-x Digitizer.
| Device ID | K121948 |
| 510k Number | K121948 |
| Device Name: | CR 10-X DIGITIZER |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | AGFA HEALTHCARE N.V. SEPTESTRAAT 27 Mortsel, BE B 2640 |
| 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 | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-07-03 |
| Decision Date | 2012-07-20 |
| Summary: | summary |