The following data is part of a premarket notification filed by Chili Gmbh with the FDA for Chili Pacs.
| Device ID | K070796 |
| 510k Number | K070796 |
| Device Name: | CHILI PACS |
| Classification | System, Image Processing, Radiological |
| Applicant | CHILI GMBH BURGSTRASSE 61 Heidelberg, Bw, DE 69121 |
| Contact | Uwe Engelmann |
| Correspondent | Stefan Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-03-23 |
| Decision Date | 2007-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260456230062 | K070796 | 000 |
| 04260456230055 | K070796 | 000 |
| 04260456230048 | K070796 | 000 |
| 04260456230031 | K070796 | 000 |
| 04260456230024 | K070796 | 000 |
| 04260456230017 | K070796 | 000 |
| 04260456230000 | K070796 | 000 |
| 04260456230079 | K070796 | 000 |