The following data is part of a premarket notification filed by General Electric Co. with the FDA for Advanced Lung Analysis-1.
| Device ID | K013381 |
| 510k Number | K013381 |
| Device Name: | ADVANCED LUNG ANALYSIS-1 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Steven J Kachelmeyer |
| Correspondent | Wolfram Gmelin TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-10-12 |
| Decision Date | 2001-10-26 |
| Summary: | summary |