I.S.G. 3DMV Workstation
FDA 510(k) K872150 · I.S.G. Technologies, Inc.
510(k) numberK872150
Submission
- Device name
- I.S.G. 3DMV Workstation
- Applicant
- I.S.G. Technologies, Inc.
Ontario L4v 1s8, CA - Received
- June 4, 1987
- Decision date
- August 12, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code JAK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253836 | FCT iStream Phase 2JAK · Traditional | Fujifilm Corporation | 09/04/2026SE |
| K253450 | BodyTom Elite (NL4000)JAK · Traditional | NeuroLogica Corp., a Samsung Company | 07/28/2026SE |
| K253770 | CardIQ SuiteJAK · Traditional | GE Medical Systems SCS | 07/21/2026SE |
| K253560 | Enhanced Boundary for PCCTJAK · Traditional | Ge Medical Systems, LLC | 06/24/2026SE |
| K253026 | Respiratory Gating for Scanners (2.1)JAK · Traditional | Varian Medical Systems, Inc. | 06/04/2026SE |
| K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0JAK · Traditional | Canon Medical Systems Corporation | 05/20/2026SE |
| K253649 | Spectral CT Verida FamilyJAK · Traditional | Philips Medical Systems Technologies , Ltd. | 03/27/2026SE |
| K253686 | True Definition DLJAK · Traditional | Ge Healthcare Japan Corporation | 03/23/2026SE |
| K252992 | CT Rembra RT; CT Areta RT; CT RembraJAK · Traditional | Philips Healthcare (Suzhou) Co., Ltd. | 03/23/2026SE |
| K253574 | SOMATOM X.cite; SOMATOM X.ceedJAK · Traditional | Siemens Medical Solutions USA, Inc. | 03/20/2026SE |
More from Siemens Medical Solutions USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K993673 | SNN Fluoro Navigation SystemHAW · Traditional | 12/21/1999SE |
| K982570 | SNN ScoutHAW · Traditional | 01/13/1999SE |
| K980684 | VR NetserveLMD · Traditional | 05/06/1998SE |
| K973413 | Id. Store (Release 2.0)LMB · Traditional | 11/25/1997SE |
| K970865 | Isg Family of Viewing WandsHAW · Traditional | 06/04/1997SE |
| K960714 | Isg Viewing WandHAW · Traditional | 05/29/1996SE |
| K941933 | Isg Medical Imaging Family of Workstations (Mifw)LLZ · Traditional | 07/29/1994SE |
| K911783 | Allegro Viewing WandLLZ · Traditional | 04/07/1994SE |
| K901679 | Resubmitted Isg 3DMV WorkstationLLZ · Traditional | 05/29/1990SE |
Questions and answers
When was I.S.G. 3DMV Workstation cleared by the FDA?
I.S.G. 3DMV Workstation (K872150) received a 510(k) decision of Substantially Equivalent on August 12, 1987, 69 days after the submission was received.
What is the product code of K872150?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.