The following data is part of a premarket notification filed by Edda Technology, Inc. with the FDA for Iqqa-liver Software.
| Device ID | K061696 |
| 510k Number | K061696 |
| Device Name: | IQQA-LIVER SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | EDDA TECHNOLOGY, INC. 14 WASHINGTON ROAD BUILDING 2 Princeton Junction, NJ 08550 |
| Contact | Xiaolan Zeng |
| Correspondent | Jeffrey D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-06-14 |
| Decision Date | 2006-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868466000244 | K061696 | 000 |