The following data is part of a premarket notification filed by Shimadzu Corporation with the FDA for Radspeed Fit.
| Device ID | K173517 |
| 510k Number | K173517 |
| Device Name: | RADspeed Fit |
| Classification | System, X-ray, Stationary |
| Applicant | SHIMADZU Corporation 1 Nishinokyo-Kuwabaracho Nakagyo-ku Kyoto, JP 604-8511 |
| Contact | Toshio Kadowaki |
| Correspondent | Jeffrey Seiler Shimadzu Medical Systems 20101 South Vermont Ave. Torrance, CA 90502 -1328 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-14 |
| Decision Date | 2018-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04540217060016 | K173517 | 000 |
| 04540217059980 | K173517 | 000 |
| 04540217062621 | K173517 | 000 |
| 04540217062577 | K173517 | 000 |