The following data is part of a premarket notification filed by Mikasa X-ray Co., Ltd. with the FDA for Minxray, Models Hfp24 And Hfp40.
| Device ID | K060566 |
| 510k Number | K060566 |
| Device Name: | MINXRAY, MODELS HFP24 AND HFP40 |
| Classification | System, X-ray, Mobile |
| Applicant | MIKASA X-RAY CO., LTD. PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm MIKASA X-RAY CO., LTD. PO BOX 7007 Deerfield, IL 60015 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-03 |
| Decision Date | 2006-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858846007246 | K060566 | 000 |
| 00858846007239 | K060566 | 000 |