510(k) K042408
- Device
- IQQA-CHEST SOFTWARE PACKAGE
- Applicant
- EDDA TECHNOLOGY, INC.
- 510(k) number
- K042408
- Product code
- OMJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-10-08
- Date received
- 2004-09-03
- Regulation
- 892.2050
- Classification name
- Chest X-ray Computer Aided Detection
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DANIEL KAMM
- Address
- P.O. Box 7007 Deer Field IL US 60015 60015
FDA Registration Numbers#
- 3004857110
Source Documents#
Legacy Summary#
summary
FDA Review#
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