I.S.G. 3DMV Workstation
by I.S.G. Technologies, Inc. 510(k)
Active
510(k) K872150
Overview
The I.S.G. 3DMV Workstation is a medical imaging device classified under product code JAK, designed for three-dimensional medical imaging and volumetric reconstruction. It functions as a workstation for processing and analyzing multi-view radiographic images, enabling detailed visualization of anatomical structures in three dimensions.
This workstation is supplied as a reusable system and is intended for use in radiology departments or imaging centers. It requires appropriate training for operation and must be maintained according to manufacturer guidelines. The device holds FDA 510(k) clearance (K872150, resubmitted as K901679) and is regulated under the Radiology advisory committee. No specific sterility or MRI safety information is provided in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK872150 | Date12 Aug 1987 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JAK
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1750
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from I.S.G. Technologies, Inc.
Questions
What is the primary purpose of the I.S.G. 3DMV Workstation in a clinical setting?
The I.S.G. 3DMV Workstation is designed for three-dimensional medical imaging and volumetric reconstruction. It processes and analyzes multi-view radiographic images to provide detailed 3D visualization of anatomical structures, which is particularly useful in radiology departments or imaging centers for enhanced diagnostic capabilities.
Is the I.S.G. 3DMV Workstation intended for single-use or reusable applications?
The I.S.G. 3DMV Workstation is supplied as a reusable system, meaning it is built to be used repeatedly in clinical environments. Proper maintenance and adherence to manufacturer guidelines are required to ensure its continued functionality and safety.
How is the I.S.G. 3DMV Workstation regulated, and what committee oversees its classification?
The I.S.G. 3DMV Workstation holds FDA 510(k) clearance and is classified under product code JAK. It is regulated under the Radiology advisory committee (RA), which reviews submissions related to radiology devices. The device was originally cleared in 1987 and later resubmitted for clearance.
Does the I.S.G. 3DMV Workstation require special training for operation, and if so, why?
Yes, the I.S.G. 3DMV Workstation requires appropriate training for operation. Since it involves complex processing and analysis of multi-view radiographic images for 3D reconstruction, proper training ensures clinicians can accurately interpret results and operate the system safely to avoid errors or misuse.
What type of facility is the I.S.G. 3DMV Workstation intended for, and why?
The I.S.G. 3DMV Workstation is intended for use in radiology departments or imaging centers. Its advanced imaging and reconstruction capabilities are best utilized in specialized environments where detailed anatomical visualization is critical for diagnostic purposes, such as orthopedics, cardiology, or complex surgical planning.