# K973368: Strait'map Option

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, Inc.
- Decided: Oct 17, 1997 after 39 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- 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 no predicate by number.

## Indications for use
The Strait’Map is intended to permit digital x-ray systems to produce distortion-free images for stereotaxy without the use of a film changer. Strait’Map corrects the geometric distortion in the digital images caused by the image intensifier. The corrected images are then sent to a laser imager for use in neuro-angiographic examinations requiring the use of a stereotactic frame. The correction procedure can be used in either monoplane or biplane configuration.

Source page: https://510kreport.com/device/K973368
Methodology: https://510kreport.com/methodology