The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Signa Pet/mr.
| Device ID | K142098 |
| 510k Number | K142098 |
| Device Name: | SIGNA PET/MR |
| Classification | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance |
| Applicant | GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Robin Martin |
| Correspondent | Robin Martin GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha, WI 53188 |
| Product Code | OUO |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-01 |
| Decision Date | 2014-11-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682107204 | K142098 | 000 |
| 00840682107082 | K142098 | 000 |
| 00840682124591 | K142098 | 000 |
| 00840682109802 | K142098 | 000 |
| 00840682107990 | K142098 | 000 |
| 00840682105699 | K142098 | 000 |
| 00840682105378 | K142098 | 000 |