K872150 is an FDA 510(k) clearance for the I.S.G. 3DMV WORKSTATION. This device is classified as a System, X-ray, Tomography, Computed (Class II - Special Controls, product code JAK).
Submitted by I.S.G. Technologies, Inc. (Ontario L4v 1s8, CA). The FDA issued a Cleared decision on August 12, 1987, 69 days after receiving the submission on June 4, 1987.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1750.
| 510(k) Number | K872150 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 1987 |
| Decision Date | August 12, 1987 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | JAK — System, X-ray, Tomography, Computed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1750 |