The following data is part of a premarket notification filed by Agfa Corporation with the FDA for Agfa Model Cr30-x.
| Device ID | K062223 |
| 510k Number | K062223 |
| Device Name: | AGFA MODEL CR30-X |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | AGFA CORPORATION 10 SOUTH ACADEMY ST. Greenville, SC 29601 |
| Contact | Patrick J Lynch |
| Correspondent | Patrick J Lynch AGFA CORPORATION 10 SOUTH ACADEMY ST. 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 | 2006-08-02 |
| Decision Date | 2006-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817100020360 | K062223 | 000 |
| 05414904017326 | K062223 | 000 |
| 05414904017333 | K062223 | 000 |
| 05414904017340 | K062223 | 000 |
| 05414904027943 | K062223 | 000 |
| 05414904027967 | K062223 | 000 |
| 05414904027998 | K062223 | 000 |
| 05414904028001 | K062223 | 000 |
| 05414904036969 | K062223 | 000 |
| 05414904044308 | K062223 | 000 |
| 05414904094174 | K062223 | 000 |
| 05414904094181 | K062223 | 000 |
| 05414904094198 | K062223 | 000 |
| 05414904094600 | K062223 | 000 |
| 05414904094617 | K062223 | 000 |
| 05414904111390 | K062223 | 000 |
| 05414904135532 | K062223 | 000 |
| 05414904017098 | K062223 | 000 |