# K974755: Dyna Vue 3-D Imaging Product

- Pathway: 510(k) (Traditional)
- Applicant: Imd Systems, Inc.
- Decided: Mar 4, 1998 after 75 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Voxel System manufactured by Voxel Digital Holography: named in the summary without a submission number
- (no number) Endolive System (3 D Endoscope) produced by Carl Zeiss Germany: named in the summary without a submission number

## Indications for use
This device will be used in the same manner as all three dimensional imaging products are used, similar to the Voxel System. It can be used with any two and three dimensional spinning image data such as MRI, CAT, DSA and Ultrasound produced data and converts the data into complete and real 3D images in rotational and static fashion. The device is used to aid the surgeon by permitting more precise morphological diagnosis especially in aneurysms, atherosclerotic lesions and bile duct carcinomas due to the improved view of the data. It may also facilitate highly selective interventional procedures for vascular surgeons because of the improved three dimensional vascular road map the physician sees. The system does not take the place of the physician it is only a tool to assist the physician in his diagnosis, it does not make the diagnosis for him. Decisions about what to do and how to perform a procedure rest firmly with the physician. This device is used primarily by physicians and health care workers, and is normally used under the supervision of a physician. It is not sold to the general public but may be available as a teaching tool to Universities and Medical Schools without the requirement of physician supervision.

Source page: https://510kreport.com/device/K974755
Methodology: https://510kreport.com/methodology