The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Discovery Nm/ct 670 Czt.
| Device ID | K153402 |
| 510k Number | K153402 |
| Device Name: | Discovery NM/CT 670 CZT |
| 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 | 2015-11-24 |
| Decision Date | 2016-01-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682145725 | K153402 | 000 |
| 00840682141635 | K153402 | 000 |
| 00840682140843 | K153402 | 000 |
| 00840682139380 | K153402 | 000 |
| 00840682123853 | K153402 | 000 |
| 00840682123778 | K153402 | 000 |
| 00840682121446 | K153402 | 000 |