The following data is part of a premarket notification filed by Agfa Healthcare Corporation with the FDA for Impax Ma3000 Diagnostic Pacs Workstation.
| Device ID | K081976 |
| 510k Number | K081976 |
| Device Name: | IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION |
| Classification | System, Image Processing, Radiological |
| Applicant | AGFA HEALTHCARE CORPORATION 10 SOUTH ACADEMY STREET Greenville, SC 29601 |
| 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 | 2008-07-11 |
| Decision Date | 2008-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414904216552 | K081976 | 000 |