The following data is part of a premarket notification filed by Agfa Healthcare N.v. with the FDA for Dr 400.
| Device ID | K141192 |
| 510k Number | K141192 |
| Device Name: | DR 400 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | AGFA HEALTHCARE N.V. 10 SOUTH ACADEMY STREET Greenville, SC 29601 |
| Contact | Shaeann Cavanagh |
| Correspondent | Shaeann Cavanagh AGFA HEALTHCARE N.V. 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 | 2014-05-08 |
| Decision Date | 2014-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414904176252 | K141192 | 000 |
| 05414904281321 | K141192 | 000 |