The following data is part of a premarket notification filed by Agfa Healthcare N.v. with the FDA for Dx-d Imaging Package.
| Device ID | K141602 |
| 510k Number | K141602 |
| Device Name: | DX-D IMAGING PACKAGE |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | AGFA HEALTHCARE N.V. 10 SOUTH ACADEMY ST. Greenville, SC 29601 |
| Contact | Shaeann Cavanagh |
| Correspondent | Shaeann Cavanagh AGFA HEALTHCARE N.V. 10 SOUTH ACADEMY ST. 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 | 2014-06-16 |
| Decision Date | 2014-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414904217818 | K141602 | 000 |
| 05414904043257 | K141602 | 000 |
| 05414904040539 | K141602 | 000 |
| 05414904040522 | K141602 | 000 |
| 05414904027905 | K141602 | 000 |
| 05414904026809 | K141602 | 000 |
| 05414904026793 | K141602 | 000 |
| 05414904026786 | K141602 | 000 |
| 05414904026618 | K141602 | 000 |
| 05414904026601 | K141602 | 000 |
| 05414904026595 | K141602 | 000 |
| 05414904026588 | K141602 | 000 |
| 05414904026571 | K141602 | 000 |
| 05414904015650 | K141602 | 000 |
| 05414904015636 | K141602 | 000 |
| 05414904015629 | K141602 | 000 |
| 05414904043264 | K141602 | 000 |
| 05414904043271 | K141602 | 000 |
| 05414904094693 | K141602 | 000 |
| 05414904094686 | K141602 | 000 |
| 05414904094679 | K141602 | 000 |
| 05414904094662 | K141602 | 000 |
| 05414904094655 | K141602 | 000 |
| 05414904094648 | K141602 | 000 |
| 05414904094631 | K141602 | 000 |
| 05414904094624 | K141602 | 000 |
| 05414904044186 | K141602 | 000 |
| 05414904044148 | K141602 | 000 |
| 05414904044131 | K141602 | 000 |
| 05414904043318 | K141602 | 000 |
| 05414904043301 | K141602 | 000 |
| 05414904043295 | K141602 | 000 |
| 05414904043288 | K141602 | 000 |
| 05414904015612 | K141602 | 000 |