The following data is part of a premarket notification filed by Edda Technology, Inc. with the FDA for Iqqa-chest Software Package.
| Device ID | K042408 |
| 510k Number | K042408 |
| Device Name: | IQQA-CHEST SOFTWARE PACKAGE |
| Classification | Chest X-ray Computer Aided Detection |
| Applicant | EDDA TECHNOLOGY, INC. P.O. BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm EDDA TECHNOLOGY, INC. P.O. BOX 7007 Deerfield, IL 60015 |
| Product Code | OMJ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-03 |
| Decision Date | 2004-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868466000206 | K042408 | 000 |