The following data is part of a premarket notification filed by I.s.g. Technologies, Inc. with the FDA for I.s.g. 3dmv Workstation.
| Device ID | K872150 |
| 510k Number | K872150 |
| Device Name: | I.S.G. 3DMV WORKSTATION |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | I.S.G. TECHNOLOGIES, INC. 3030 ORLANDO DR. MISSISSAUGA Ontario L4v 1s8, CA |
| Contact | Irene Gearin |
| Correspondent | Irene Gearin I.S.G. TECHNOLOGIES, INC. 3030 ORLANDO DR. MISSISSAUGA Ontario L4v 1s8, CA |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-04 |
| Decision Date | 1987-08-12 |