510(k) K042408
K042408 is an FDA 510(k) premarket notification submitted by Edda Technology, Inc. for the device "IQQA-CHEST SOFTWARE PACKAGE". The FDA issued a decision of Substantially Equivalent on October 8, 2004. The device falls under product code OMJ (Chest X-Ray Computer Aided Detection), a Class II device regulated under 21 CFR 892.2050. Edda Technology, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 2004
- Date Received
- September 3, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chest X-Ray Computer Aided Detection
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type
To assist radiologists in the review of chest radiographic images and highlight potential nodules that the radiologist should review.