The following data is part of a premarket notification filed by Ge Medical Systems Israel, Functional Imaging with the FDA for Discovery Nm 750b.
| Device ID | K102231 |
| 510k Number | K102231 |
| Device Name: | DISCOVERY NM 750B |
| Classification | Camera, Scintillation (gamma) |
| Applicant | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4 HAYOZMA STREET Tirat Hacarmel, IL 30200 |
| Contact | Eli Werner |
| Correspondent | Eli Werner GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4 HAYOZMA STREET Tirat Hacarmel, IL 30200 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-09 |
| Decision Date | 2010-11-03 |
| Summary: | summary |