The following data is part of a premarket notification filed by Pacsgear, Inc. with the FDA for Pacs Scan.
| Device ID | K083618 |
| 510k Number | K083618 |
| Device Name: | PACS SCAN |
| Classification | System, Image Processing, Radiological |
| Applicant | PACSGEAR, INC. 1705 S. CAPITOL OF TEXAS HWY. SUITE 500 Austin, TX 78746 |
| Contact | Ian Gordon |
| Correspondent | Ian Gordon PACSGEAR, INC. 1705 S. CAPITOL OF TEXAS HWY. SUITE 500 Austin, TX 78746 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-08 |
| Decision Date | 2009-01-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850677007112 | K083618 | 000 |
| 00850677007105 | K083618 | 000 |
| 00850677007051 | K083618 | 000 |
| 00850677007006 | K083618 | 000 |
| 00850677007341 | K083618 | 000 |
| 00850677007334 | K083618 | 000 |