The following data is part of a premarket notification filed by Globus Industries with the FDA for Im512p.
| Device ID | K945792 |
| 510k Number | K945792 |
| Device Name: | IM512P |
| Classification | Camera, Scintillation (gamma) |
| Applicant | GLOBUS INDUSTRIES 2124 HIGHWAY 35 Holmdel, NJ 07733 |
| Contact | James Zalayet |
| Correspondent | James Zalayet GLOBUS INDUSTRIES 2124 HIGHWAY 35 Holmdel, NJ 07733 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-25 |
| Decision Date | 1995-05-24 |