The following data is part of a premarket notification filed by Siemens Corp. with the FDA for Perfusion Ct (computed Tomography) Software Package.
| Device ID | K982536 |
| 510k Number | K982536 |
| Device Name: | PERFUSION CT (COMPUTED TOMOGRAPHY) SOFTWARE PACKAGE |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SIEMENS CORP. 186 WOOD AVE., SOUTH Iselin, NJ 08830 |
| Contact | Malgorzata Stanek |
| Correspondent | Malgorzata Stanek SIEMENS CORP. 186 WOOD AVE., 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 | 1998-07-21 |
| Decision Date | 1998-11-24 |
| Summary: | summary |