510(k) K033412
K033412 is an FDA 510(k) premarket notification submitted by Medicsight for the device "MEDICLUNG, RELEASE 1". The FDA issued a decision of Substantially Equivalent on December 30, 2003. The device falls under product code OEB (Lung Computed Tomography System, Computer-Aided Detection), a Class II device regulated under 21 CFR 892.2050. Medicsight has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 2003
- Date Received
- October 27, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
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.