The following data is part of a premarket notification filed by Medx, Inc. with the FDA for T-quest System.
| Device ID | K073456 |
| 510k Number | K073456 |
| Device Name: | T-QUEST SYSTEM |
| Classification | Camera, Scintillation (gamma) |
| Applicant | MEDX, INC. 3456 NORTH RIDGE AVE., #100 Arlington Heights, IL 60004 |
| Contact | Michael Hanushewsky |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-12-10 |
| Decision Date | 2007-12-20 |
| Summary: | summary |