IQQA-CHEST SOFTWARE PACKAGE
FDA 510(k) clearance K042408 · decided 2004-10-08
Clearance details
- K-number
- K042408
- Device name
- IQQA-CHEST SOFTWARE PACKAGE
- Applicant
- Edda Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-09-03
- Decision date
- 2004-10-08
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- OMJ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Deer Field, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.