The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Pet Digital Gating.
| Device ID | K180318 |
| 510k Number | K180318 |
| Device Name: | PET Digital Gating |
| Classification | System, Tomography, Computed, Emission |
| Applicant | GE Medical Systems, LLC 3000 N. Grandview Blvd. Waukesha, WI 53188 |
| Contact | Lee Bush |
| Correspondent | Lee Bush 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 | 2018-02-05 |
| Decision Date | 2018-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682141994 | K180318 | 000 |