The following data is part of a premarket notification filed by I.s.g. Technologies, Inc. with the FDA for Resubmitted Isg 3dmv Workstation.
| Device ID | K901679 |
| 510k Number | K901679 |
| Device Name: | RESUBMITTED ISG 3DMV WORKSTATION |
| Classification | System, Image Processing, Radiological |
| Applicant | I.S.G. TECHNOLOGIES, INC. 3030 ORLANDO DR. MISSISSAUGA Ontario L4v 1s8, CA |
| Contact | William M Weston,md |
| Correspondent | William M Weston,md I.S.G. TECHNOLOGIES, INC. 3030 ORLANDO DR. MISSISSAUGA Ontario L4v 1s8, CA |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-12 |
| Decision Date | 1990-05-29 |