The following data is part of a premarket notification filed by Agfa Healthcare N.v. with the FDA for Cr 12-x Digitizer.
| Device ID | K131408 |
| 510k Number | K131408 |
| Device Name: | CR 12-X DIGITIZER |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | AGFA HEALTHCARE N.V. 10 S ACADEMY STREET Greenville, SC 29601 |
| Contact | Shaeann Cavanagh |
| Correspondent | Shaeann Cavanagh AGFA HEALTHCARE N.V. 10 S ACADEMY STREET Greenville, SC 29601 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-15 |
| Decision Date | 2013-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414904209752 | K131408 | 000 |
| 05414904160725 | K131408 | 000 |
| 05414904160718 | K131408 | 000 |
| 05414904160701 | K131408 | 000 |
| 05414904160480 | K131408 | 000 |
| 05414904160473 | K131408 | 000 |
| 05414904151327 | K131408 | 000 |
| 05414904151310 | K131408 | 000 |
| 05414904092545 | K131408 | 000 |
| 05414904092538 | K131408 | 000 |
| 05414904160732 | K131408 | 000 |
| 05414904160749 | K131408 | 000 |
| 05414904188903 | K131408 | 000 |
| 05414904188897 | K131408 | 000 |
| 05414904188880 | K131408 | 000 |
| 05414904180600 | K131408 | 000 |
| 05414904180389 | K131408 | 000 |
| 05414904160787 | K131408 | 000 |
| 05414904160770 | K131408 | 000 |
| 05414904160763 | K131408 | 000 |
| 05414904160756 | K131408 | 000 |
| 05414904092521 | K131408 | 000 |