The following data is part of a premarket notification filed by Amicas, Inc. with the FDA for Amicas Pacs, Version 6.0.
| Device ID | K082144 |
| 510k Number | K082144 |
| Device Name: | AMICAS PACS, VERSION 6.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | AMICAS, INC. 20 GUEST ST. Boston, MA 02135 |
| Contact | Patrice Jc Nedelec |
| Correspondent | Patrice Jc Nedelec AMICAS, INC. 20 GUEST ST. Boston, MA 02135 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-30 |
| Decision Date | 2008-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842000100607 | K082144 | 000 |
| 00842000100577 | K082144 | 000 |
| 00842000100560 | K082144 | 000 |
| 00842000100508 | K082144 | 000 |
| 00842000100409 | K082144 | 000 |
| 00842000100133 | K082144 | 000 |
| 00842000100072 | K082144 | 000 |
| 00842000100478 | K082144 | 000 |