The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Calcium Scoring.
| Device ID | K990426 |
| 510k Number | K990426 |
| Device Name: | CALCIUM SCORING |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVE. SOUTH Iselin, NJ 08830 |
| Contact | Alicia Bustos-juergensen |
| Correspondent | Alicia Bustos-juergensen SIEMENS MEDICAL SOLUTIONS USA, INC. 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 | 1999-02-11 |
| Decision Date | 1999-05-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869026343 | K990426 | 000 |
| 04056869013879 | K990426 | 000 |
| 04056869007786 | K990426 | 000 |