The following data is part of a premarket notification filed by Agfa Healthcare N.v. with the FDA for Impax Next Generation.
| Device ID | K111945 |
| 510k Number | K111945 |
| Device Name: | IMPAX NEXT GENERATION |
| Classification | System, Image Processing, Radiological |
| Applicant | AGFA HEALTHCARE N.V. SEPTESTRAAT 27 Mortsel, BE B 2640 |
| Contact | Jodi Coleman |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-07-08 |
| Decision Date | 2011-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414904252437 | K111945 | 000 |