The following data is part of a premarket notification filed by Agfa Corp. with the FDA for Afga Cr25.0 Computed Radiography System.
| Device ID | K041701 |
| 510k Number | K041701 |
| Device Name: | AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | AGFA CORP. 10 SOUTH ACADEMY ST. Greenville, SC 29601 |
| Contact | Jeffery A Jedlicka |
| Correspondent | Jeffery A Jedlicka AGFA CORP. 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 | 2004-06-22 |
| Decision Date | 2004-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414904175811 | K041701 | 000 |
| 05414904028988 | K041701 | 000 |
| 05414904028971 | K041701 | 000 |
| 05414904027516 | K041701 | 000 |
| 05414904027509 | K041701 | 000 |
| 05414904027363 | K041701 | 000 |
| 05414904027226 | K041701 | 000 |
| 05414904027219 | K041701 | 000 |
| 05414904027202 | K041701 | 000 |
| 05414904027158 | K041701 | 000 |
| 05414904018200 | K041701 | 000 |
| 05414904028995 | K041701 | 000 |
| 05414904029008 | K041701 | 000 |
| 05414904172384 | K041701 | 000 |
| 05414904151938 | K041701 | 000 |
| 05414904044100 | K041701 | 000 |
| 05414904038840 | K041701 | 000 |
| 05414904029220 | K041701 | 000 |
| 05414904029213 | K041701 | 000 |
| 05414904029206 | K041701 | 000 |
| 05414904029039 | K041701 | 000 |
| 05414904029022 | K041701 | 000 |
| 05414904029015 | K041701 | 000 |
| 05414904018194 | K041701 | 000 |