The following data is part of a premarket notification filed by Medsphere Technologies Pvt Ltd. with the FDA for Instarad.
| Device ID | K080334 |
| 510k Number | K080334 |
| Device Name: | INSTARAD |
| Classification | System, Image Processing, Radiological |
| Applicant | MEDSPHERE TECHNOLOGIES PVT LTD. 1600 MANCHESTER WAY Corinth, TX 76210 |
| Contact | Carl Alletto |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-02-07 |
| Decision Date | 2008-02-21 |
| Summary: | summary |