The following data is part of a premarket notification filed by Agfa Healthcare N.v. with the FDA for Cr Mammography System With Dx-m Digitizer.
| Device ID | K111324 |
| 510k Number | K111324 |
| Device Name: | CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| Applicant | AGFA HEALTHCARE N.V. 10 S ACADEMY STREET Greenville, SC 29601 |
| Contact | Phil Cuscuna |
| Correspondent | Phil Cuscuna AGFA HEALTHCARE N.V. 10 S ACADEMY STREET Greenville, SC 29601 |
| Product Code | MUE |
| CFR Regulation Number | 892.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-11 |
| Decision Date | 2011-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414904050385 | K111324 | 000 |
| 05414904044179 | K111324 | 000 |
| 05414904044162 | K111324 | 000 |
| 05414904044155 | K111324 | 000 |