FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IQQA-CHEST SOFTWARE PACKAGE
K Number: K042408
·
Decision Oct 8, 2004
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
3
Review Days
35
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Basic Information
- Device Name
- IQQA-CHEST SOFTWARE PACKAGE
- K Number
- K042408
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Edda Technology, Inc.
- Date Received
- September 3, 2004
- Decision Date
- October 8, 2004
- Product Code
- OMJ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OMJ | Chest X-Ray Computer Aided Detection | FDA class 2 | Radiology |