The following data is part of a premarket notification filed by Agfa Healthcare N.v. with the FDA for Dx-d 300.
| Device ID | K103050 |
| 510k Number | K103050 |
| Device Name: | DX-D 300 |
| Classification | System, X-ray, Stationary |
| Applicant | AGFA HEALTHCARE N.V. 10 S ACADEMY STREET Greenville, SC 29601 |
| Contact | Phil Cuscuna |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-10-15 |
| Decision Date | 2010-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414904079607 | K103050 | 000 |