The following data is part of a premarket notification filed by Edda Technology, Inc. with the FDA for Iqqa-liver Multimodality Software.
| Device ID | K131498 |
| 510k Number | K131498 |
| Device Name: | IQQA-LIVER MULTIMODALITY SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | EDDA TECHNOLOGY, INC. 5 Independence Way Princeton, NJ 08540 |
| Contact | Daniel Kamm, P.e. |
| Correspondent | Daniel Kamm, P.e. EDDA TECHNOLOGY, INC. 5 Independence Way Princeton, NJ 08540 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-24 |
| Decision Date | 2013-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868466000213 | K131498 | 000 |