# K243227: B-Scan

- Pathway: 510(k) (Traditional)
- Applicant: Accutome, Inc. Doing Business AS Keeler USA
- Decided: Jul 11, 2025 after 276 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K871536 (1987). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070943: B-Scan Plus, Accutome Ultrasound, Inc. (2007) Summary page 6.

## Indications for use
The B-Scan module is used for imaging the internal structure of the eye, including the opaque media and posterior pathology, for the purpose of diagnosing pathological or traumatic conditions in the eye. The probe is intended to be used on both adult and pediatric patients that require imaging of the eye.

Source page: https://510kreport.com/device/K243227
Methodology: https://510kreport.com/methodology