The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Shimadzu Mobile X-ray System Mobile Art Evolution.
| Device ID | K090268 |
| 510k Number | K090268 |
| Device Name: | SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION |
| Classification | System, X-ray, Mobile |
| Applicant | SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Contact | Don Karle |
| Correspondent | Don Karle SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-03 |
| Decision Date | 2009-06-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04540217053513 | K090268 | 000 |