The following data is part of a premarket notification filed by Intuitive Imaging Informatics, Llc with the FDA for Imageqube Pacs.
| Device ID | K051037 |
| 510k Number | K051037 |
| Device Name: | IMAGEQUBE PACS |
| Classification | System, Image Processing, Radiological |
| Applicant | INTUITIVE IMAGING INFORMATICS, LLC 30 HACKAMORE LN., SUITE 4 Bell Canyon, CA 91307 |
| Contact | Donald Mundt |
| Correspondent | Morten Simon Christensen UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara, CA 95050 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-04-25 |
| Decision Date | 2005-06-28 |
| Summary: | summary |