The following data is part of a premarket notification filed by Imaging Sciences Intl., Inc. with the FDA for Dvt Scanner.
| Device ID | K051980 |
| 510k Number | K051980 |
| Device Name: | DVT SCANNER |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | IMAGING SCIENCES INTL., INC. 1910 NORTH PENN RD. Hatfield, PA 19440 |
| Contact | David W Cowan |
| Correspondent | David W Cowan IMAGING SCIENCES INTL., INC. 1910 NORTH PENN RD. Hatfield, PA 19440 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-21 |
| Decision Date | 2005-08-19 |
| Summary: | summary |