# K153416: ArcScan Insight 100

- Pathway: 510(k) (Special)
- Applicant: Arcscan, Inc.
- Decided: Feb 2, 2016 after 69 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: 2 generations back to K003890 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021333: Artemis, Ultralink, LLC (2002) Summary page 5.

## Indications for use
The ArcScan Insight 100 is indicated for use in adults to measure dimensions of components of the human eye. To provide tomographic, high-resolution ultrasound images of the anterior portion of the eye. It is also designed to measure these tissues and structures, such as anterior chamber depth, angle-to-angle width and sulcus-to-sulcus width. Measurements can be made of the cornea and its individual layers including the epithelium, stroma, and surgically induced surfaces. Measurement also may be made of pathological structures such as solid masses or cysts and it is therefore useful in evaluation and/or planning of refractive surgery and evaluation of pathologies of the anterior segment such as trauma, tumors, cysts, glaucoma and hypotony.

Source page: https://510kreport.com/device/K153416
Methodology: https://510kreport.com/methodology