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 |