The following data is part of a premarket notification filed by Jaguar Technology Limited with the FDA for Imagesvr Pacs.
| Device ID | K082808 |
| 510k Number | K082808 |
| Device Name: | IMAGESVR PACS |
| Classification | System, Image Processing, Radiological |
| Applicant | JAGUAR TECHNOLOGY LIMITED NO. 58, FU CHIUN STREET Hsin Chu City, TW 30067 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen JAGUAR TECHNOLOGY LIMITED NO. 58, FU CHIUN STREET Hsin Chu City, TW 30067 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-24 |
| Decision Date | 2009-01-09 |
| Summary: | summary |