The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Cortex Id Suite.
| Device ID | K141074 |
| 510k Number | K141074 |
| Device Name: | CORTEX ID SUITE |
| Classification | System, Tomography, Computed, Emission |
| Applicant | GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | David Duersteler |
| Correspondent | Jeme Wallace GE MEDICAL SYSTEMS, LLC 540 W. NORTHWEST HWY. Barrington, IL 60010 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-25 |
| Decision Date | 2014-09-18 |
| Summary: | summary |