The following data is part of a premarket notification filed by Hybridyne Imaging Technologies, Inc with the FDA for Proxiscan Model 101.
| Device ID | K093706 |
| 510k Number | K093706 |
| Device Name: | PROXISCAN MODEL 101 |
| Classification | Camera, Scintillation (gamma) |
| Applicant | HYBRIDYNE IMAGING TECHNOLOGIES, INC 195 WEST STREET Waltham, MA 02451 |
| Contact | Barry S Sall, Rac |
| Correspondent | Barry S Sall, Rac HYBRIDYNE IMAGING TECHNOLOGIES, INC 195 WEST STREET Waltham, MA 02451 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-01 |
| Decision Date | 2010-04-02 |
| Summary: | summary |