The following data is part of a premarket notification filed by Medqia with the FDA for Ibis Explorer And Markup Software.
| Device ID | K111319 |
| 510k Number | K111319 |
| Device Name: | IBIS EXPLORER AND MARKUP SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | MEDQIA 924 WESTWOOD BLVD SUITE 615 Los Angeles, CA 90024 |
| Contact | Mahtab Fatemi |
| 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 | 2011-05-10 |
| Decision Date | 2011-08-05 |
| Summary: | summary |