The following data is part of a premarket notification filed by Agfa Healthcare N.v. with the FDA for Dr 600.
| Device ID | K152639 |
| 510k Number | K152639 |
| Device Name: | DR 600 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | AGFA HEALTHCARE N.V. SEPTESTRAAT 27 Mortsel, BE B 2640 |
| Contact | Koren Vervoort |
| Correspondent | Shaeann Cavanagh AGFA HEALTHCARE CORP. 10 SOUTH ACADEMY STREET Greenville, SC 29601 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-15 |
| Decision Date | 2015-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414904197202 | K152639 | 000 |
| 05414904196298 | K152639 | 000 |