The following data is part of a premarket notification filed by Shimadzu Corporation with the FDA for Radspeed Pro.
| Device ID | K152244 |
| 510k Number | K152244 |
| Device Name: | RADspeed Pro |
| Classification | System, X-ray, Stationary |
| Applicant | SHIMADZU CORPORATION 1 Nishinokyo-Kuwabaracho Nakagyo-ku Kyoto, JP 604-8511 |
| Contact | Toshio Kadowaki |
| Correspondent | Toshio Kadowaki SHIMADZU MEDICAL SYSTEMS 1, Nishinokyo-Kuwabaracho, Nakagyo-ku Kyoto, JP |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-10 |
| Decision Date | 2016-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04540217059959 | K152244 | 000 |
| 04540217052356 | K152244 | 000 |
| 04540217040315 | K152244 | 000 |
| 04540217040308 | K152244 | 000 |
| 04540217040292 | K152244 | 000 |
| 04540217060269 | K152244 | 000 |
| 04540217060252 | K152244 | 000 |
| 04540217060245 | K152244 | 000 |
| 04540217060238 | K152244 | 000 |
| 04540217052363 | K152244 | 000 |
| 04540217052370 | K152244 | 000 |
| 04540217052387 | K152244 | 000 |
| 04540217059942 | K152244 | 000 |
| 04540217052493 | K152244 | 000 |
| 04540217052486 | K152244 | 000 |
| 04540217052479 | K152244 | 000 |
| 04540217052424 | K152244 | 000 |
| 04540217052417 | K152244 | 000 |
| 04540217052400 | K152244 | 000 |
| 04540217052394 | K152244 | 000 |
| 04540217060221 | K152244 | 000 |