The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Lungcare Ct Software Package.
| Device ID | K022013 |
| 510k Number | K022013 |
| Device Name: | LUNGCARE CT SOFTWARE PACKAGE |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
| Contact | Praveen P Nadkarni |
| 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 | 2002-06-20 |
| Decision Date | 2002-07-16 |
| Summary: | summary |