The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Nm/ct 850, Nm/ct 860.
| Device ID | K173816 |
| 510k Number | K173816 |
| Device Name: | NM/CT 850, NM/CT 860 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | GE Healthcare 4 Hayozma Street Tirat Hacarmel, IL 30200 |
| Contact | George Mashour |
| Correspondent | George Mashour GE Healthcare 4 Hayozma Street Tirat Hacarmel, IL 30200 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-15 |
| Decision Date | 2018-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682145497 | K173816 | 000 |
| 00840682145473 | K173816 | 000 |
| 00840682145442 | K173816 | 000 |
| 00840682145930 | K173816 | 000 |
| 00840682145527 | K173816 | 000 |
| 00840682145510 | K173816 | 000 |
| 00840682145480 | K173816 | 000 |
| 00840682140775 | K173816 | 000 |
| 00840682140751 | K173816 | 000 |