K901679 is an FDA 510(k) clearance for the RESUBMITTED ISG 3DMV WORKSTATION. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by I.S.G. Technologies, Inc. (Ontario L4v 1s8, CA). The FDA issued a Cleared decision on May 29, 1990, 47 days after receiving the submission on April 12, 1990.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K901679 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 1990 |
| Decision Date | May 29, 1990 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | LLZ — System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |