The following data is part of a premarket notification filed by Agfa Healthcare Corporation with the FDA for Drystar Axys, Model Eyz4e.
| Device ID | K072680 |
| 510k Number | K072680 |
| Device Name: | DRYSTAR AXYS, MODEL EYZ4E |
| Classification | Camera, Multi Format, Radiological |
| Applicant | AGFA HEALTHCARE CORPORATION 10 SOUTH ACADEMY ST. Greenville, SC 29601 |
| Contact | Patrick J Lynch |
| Correspondent | Patrick J Lynch AGFA HEALTHCARE CORPORATION 10 SOUTH ACADEMY ST. Greenville, SC 29601 |
| Product Code | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2007-09-24 |
| Decision Date | 2007-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414904200520 | K072680 | 000 |
| 05414904161487 | K072680 | 000 |
| 05414904015667 | K072680 | 000 |