The following data is part of a premarket notification filed by Agfa Healthcare N.v. with the FDA for Impax Agility.
| Device ID | K142316 |
| 510k Number | K142316 |
| Device Name: | IMPAX Agility |
| Classification | System, Image Processing, Radiological |
| Applicant | AGFA HEALTHCARE N.V. SEPTESTRAAT 27 Mortsel, BE B 2640 |
| Contact | Jodi Coleman |
| Correspondent | Shaeann Cavanagh AGFA HEALTHCARE CORP. 10 SOUTH ACADEMY ST. Greenville, SC 29601 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-19 |
| Decision Date | 2015-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414904252437 | K142316 | 000 |
| 05414904242902 | K142316 | 000 |
| 05414904218525 | K142316 | 000 |