The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Pulmo Ct With Reference Database For The Somatom Plus And Plus 4 Computed Tomography Systems.
| Device ID | K960635 |
| 510k Number | K960635 |
| Device Name: | PULMO CT WITH REFERENCE DATABASE FOR THE SOMATOM PLUS AND PLUS 4 COMPUTED TOMOGRAPHY SYSTEMS |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
| Contact | Jing Zhang |
| Correspondent | Jing Zhang SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-14 |
| Decision Date | 1996-04-03 |
| Summary: | summary |