510(k) K041380
K041380 is an FDA 510(k) premarket notification submitted by R2 Technology, Inc. for the device "IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR". The FDA issued a decision of Substantially Equivalent on June 8, 2004. The device falls under product code OEB (Lung Computed Tomography System, Computer-Aided Detection), a Class II device regulated under 21 CFR 892.2050. R2 Technology, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 8, 2004
- Date Received
- May 25, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Lung Computed Tomography System, Computer-Aided Detection
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type
To assist radiologists in the review of multi-slice computed tomography (msct) exams of the chest and highlight potential nodules that the radiologist should review. A computer aided diagnosis, lung computed tomography system is a class 3 device under product code NRR.