The following data is part of a premarket notification filed by Imaging Sciences Intl., Inc. with the FDA for Xr-910.
| Device ID | K981466 |
| 510k Number | K981466 |
| Device Name: | XR-910 |
| Classification | System, X-ray, Mobile |
| Applicant | IMAGING SCIENCES INTL., INC. 941 HAMILTON AVE. Roebling, NJ 08554 |
| Contact | Robert E Hay |
| Correspondent | Robert E Hay IMAGING SCIENCES INTL., INC. 941 HAMILTON AVE. Roebling, NJ 08554 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-23 |
| Decision Date | 1998-07-14 |
| Summary: | summary |