The following data is part of a premarket notification filed by Statrad, Llc with the FDA for Stat Pacs Picture Archiving & Communication System (pacs).
| Device ID | K092134 |
| 510k Number | K092134 |
| Device Name: | STAT PACS PICTURE ARCHIVING & COMMUNICATION SYSTEM (PACS) |
| Classification | System, Image Processing, Radiological |
| Applicant | STATRAD, LLC 4747 VIEWRIDGE AVE. SUITE 107 San Diego, CA 92123 |
| 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 | 2009-07-15 |
| Decision Date | 2009-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860257001102 | K092134 | 000 |