# K201743: ClarifEye R1.0, ClarifEye Needle

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems Nederlands B.V.
- Decided: Feb 23, 2021 after 243 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K801623 (1980). 72 ancestors in all.
No later device cites it as a predicate yet.
1 of 73 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131263: Xperguide, Philips Medical Systems Nederland B.V. (2013) Summary page 4.
- K140868: Stryker Kwic Needle, Orthovita, Inc. (2014) Summary page 6.

## Indications for use
ClarifEye is intended to be an intra-operative image-guidance tool used during surgical and interventional therapy. It provides assistance to the performing physician to align a device with a virtual path that is planned on a 3D volume of the anatomy. This alignment is provided in the following ways: -The virtual path is superimposed with a live video image of the area of interest. -The position of the ClarifEye Needle is superimposed with the video images of the area of interest and/or the 3D images of the anatomy. ClarifEye is intended to be used on patients who have been elected for procedures where a straight, rigid device is placed in the spine, such as sacral, lumbar and thoracic pedicle screw placement. ClarifEye is indicated for procedures where a reference to bony anatomical structures can be established using skin markers as a reference. The ClarifEye Needle is a manual, surgical instrument intended to be used during spine surgery to facilitate placement of guidewires. The needle may be used as part of a planning and intraoperative guidance system (i.e. Philips intra-operative image guidance tool) to enable open or percutaneous image guided therapy. The ClarifEye Needle is indicated for use during posterior pedicle screw procedures, such as in the sacral, lumbar and thoracic spinal regions, in which the use of image guided surgery may be appropriate. The ClarifEye Needle is EtO sterilized, for single use only and have to be disposed after use, according to local waste disposal methods for potentially bio hazardous material.

Source page: https://510kreport.com/device/K201743
Methodology: https://510kreport.com/methodology