# K021333: Artemis

- Pathway: 510(k) (Traditional)
- Applicant: Ultralink, LLC
- Decided: Oct 8, 2002 after 165 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: 1 generation back to K003890 (2001). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003890: VHF Ultrasonic Arc-Scan System, Ultralink, LLC (2001) Summary page 1.

## Most influential descendants
- K153416: ArcScan Insight 100 (2016), 0 descendants of its own
- K051304: Iscience Surgical Ophthalmic Imaging System (2005), 0 descendants of its own

## Indications for use
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. Measurement also may be made of pathologic structures such as solid masses or cysts and it therefore is 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/K021333
Methodology: https://510kreport.com/methodology