# DEN130051: Pediatric Vision Scanner

- Pathway: De Novo (Direct)
- Applicant: Rebiscan, Inc.
- Decided: Jun 8, 2016 after 908 days
- Product code: PMW (Strabismus Detection Device)
- Device class: 2
- Regulation: 21 CFR 886.1342
- 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. De Novo decisions do not claim a predicate device.

## Indications for use
The Pediatric Vision Scanner is intended for the automated detection of misalignment of the visual axes using polarized light. It is indicated for the screening of amblyopia and microstrabismus associated with amblyopia in children age 2 to 8 undergoing evaluation in a professional eye care setting and who are responsive to taking direction and who can pay attention for at least 5 seconds.

Source page: https://510kreport.com/device/DEN130051
Methodology: https://510kreport.com/methodology