K042694 is an FDA 510(k) clearance for the ADVANCED LUNG ANALYSIS II. This device is classified as a Lung Computed Tomography System, Computer-aided Detection (Class II - Special Controls, product code OEB).
Submitted by GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on November 18, 2004, 49 days after receiving the submission on September 30, 2004.
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 | K042694 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2004 |
| Decision Date | November 18, 2004 |
| Days to Decision | 49 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. |