The following data is part of a premarket notification filed by Cascination Ag with the FDA for Cas-one Ir.
| Device ID | K152473 |
| 510k Number | K152473 |
| Device Name: | CAS-One IR |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | CAScination AG Steigerhubelstrasse 3 Bern, CH 3008 |
| Contact | Matthias Peterehans |
| Correspondent | Matthias Peterehans CAScination AG Steigerhubelstrasse 3 Bern, CH 3008 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-31 |
| Decision Date | 2016-01-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640167222131 | K152473 | 000 |