The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Dual Energy System Package.
| Device ID | K132813 |
| 510k Number | K132813 |
| Device Name: | DUAL ENERGY SYSTEM PACKAGE |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | TOSHIBA MEDICAL SYSTEMS CORPORATION 2441 MICHELLE DRIVE Tustin, CA 92780 |
| Contact | Paul Biggins |
| Correspondent | Paul Biggins TOSHIBA MEDICAL SYSTEMS CORPORATION 2441 MICHELLE DRIVE Tustin, CA 92780 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-09 |
| Decision Date | 2014-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670104121 | K132813 | 000 |
| 04987670103810 | K132813 | 000 |
| 04987670102912 | K132813 | 000 |
| 04987670102691 | K132813 | 000 |
| 04987670102608 | K132813 | 000 |
| 04987670102202 | K132813 | 000 |