K043617 is an FDA 510(k) clearance for the IMAGECHECKER CT CAD SOFTWARE SYSTEM. This device is classified as a Lung Computed Tomography System, Computer-aided Detection (Class II - Special Controls, product code OEB).
Submitted by Hologic, Inc. (Bedford, US). The FDA issued a Cleared decision on December 21, 2007, 25 days after receiving the submission on November 26, 2007.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050. 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..
| 510(k) Number | K043617 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 2007 |
| Decision Date | December 21, 2007 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | OEB — Lung Computed Tomography System, Computer-aided Detection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |
| Definition | 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. |