The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Advanced Lung Analysis Ii.
| Device ID | K042694 |
| 510k Number | K042694 |
| Device Name: | ADVANCED LUNG ANALYSIS II |
| Classification | Lung Computed Tomography System, Computer-aided Detection |
| Applicant | GE MEDICAL SYSTEMS 3000 NORTH GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Larry A Kroger |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | OEB |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-09-30 |
| Decision Date | 2004-11-18 |
| Summary: | summary |