The following data is part of a premarket notification filed by Edda Technology with the FDA for Iqqa-bodyimaging Software.
| Device ID | K141745 |
| 510k Number | K141745 |
| Device Name: | IQQA-BODYIMAGING SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | EDDA TECHNOLOGY 5 Independence Way Princeton, NJ 08540 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm EDDA TECHNOLOGY 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 | 2014-06-30 |
| Decision Date | 2014-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868466000220 | K141745 | 000 |