The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Discovery Iq.
| Device ID | K141477 |
| 510k Number | K141477 |
| Device Name: | DISCOVERY IQ |
| Classification | System, Tomography, Computed, Emission |
| Applicant | GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Huy Doan |
| Correspondent | Huy Doan GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha, WI 53188 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-04 |
| Decision Date | 2014-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682146357 | K141477 | 000 |
| 00840682125703 | K141477 | 000 |
| 00840682103107 | K141477 | 000 |