The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Discovery Nm 630.
| Device ID | K111445 |
| 510k Number | K111445 |
| Device Name: | DISCOVERY NM 630 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | GE HEALTHCARE 4 HAYOZMA STREET Tirat Hacarmel, IL 30200 |
| Contact | Tal Bresler-stramer |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-05-24 |
| Decision Date | 2011-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682140829 | K111445 | 000 |
| 00840682139274 | K111445 | 000 |
| 00840682123761 | K111445 | 000 |
| 00840682115292 | K111445 | 000 |
| 00840682145503 | K111445 | 000 |
| 00195278788252 | K111445 | 000 |