The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Apex 115 Nuclear Medicine Processor.
| Device ID | K884672 |
| 510k Number | K884672 |
| Device Name: | APEX 115 NUCLEAR MEDICINE PROCESSOR |
| Classification | Camera, Scintillation (gamma) |
| Applicant | ELSCINT, INC. 930 COMMONWEALTH AVE. Boston, MA 02215 |
| Contact | Sobel |
| Correspondent | Sobel ELSCINT, INC. 930 COMMONWEALTH AVE. Boston, MA 02215 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-08 |
| Decision Date | 1989-04-17 |