The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Digital Radiography System Radspeed Safire.
| Device ID | K050925 |
| 510k Number | K050925 |
| Device Name: | DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Contact | Randal Walker |
| Correspondent | Randal Walker SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-13 |
| Decision Date | 2005-06-01 |