The following data is part of a premarket notification filed by Agfa Healthcare Corp. with the FDA for Impax Se Sigmacom Client (pacs Workstation).
| Device ID | K071297 |
| 510k Number | K071297 |
| Device Name: | IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION) |
| Classification | System, Image Processing, Radiological |
| Applicant | AGFA HEALTHCARE CORP. 10 SOUTH ACADEMY ST. Greenville, SC 29601 |
| Contact | Tom Holbrook |
| Correspondent | Tom Holbrook 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 | 2007-05-09 |
| Decision Date | 2007-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414904271124 | K071297 | 000 |