The following data is part of a premarket notification filed by Medx, Inc. with the FDA for Medx Nuquest - Intecam Spect 37-75 System.
| Device ID | K041840 |
| 510k Number | K041840 |
| Device Name: | MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM |
| Classification | System, Tomography, Computed, Emission |
| Applicant | MEDX, INC. 3456 NORTH RIDGE AVE., #100 Arlington Heights, IL 60004 |
| Contact | Floyd R Rowan |
| Correspondent | Floyd R Rowan MEDX, INC. 3456 NORTH RIDGE AVE., #100 Arlington Heights, IL 60004 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-08 |
| Decision Date | 2004-08-20 |
| Summary: | summary |