# K212412: Iris-XP

- Pathway: 510(k) (Traditional)
- Applicant: Medicore Co., Ltd.
- Decided: Sep 13, 2021 after 41 days
- Product code: LHQ (System, Telethermographic (Adjunctive Use))
- Device class: 1
- Regulation: 21 CFR 884.2980
- 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 K003332 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003332: Meditherm MED2000, Meditherm, Inc. (2001) Summary page 5.

## Indications for use
The IRIS XP is a thermal based imaging device intended for measuring relative skin temperature generated by the human body in the clinical, hospital, acute care settings, surgery, healthcare practitioner facilities or in any environment where healthcare is provided by a qualified healthcare professional. (for adjunctive use only) The IRIS XP provides for use with both laptop and desktop computers. The computer provides the user interface, image storage and display. Use of this device is determined by the healthcare professional and is based upon his or her of the patient's medical condition and requirements. The patient populations include all assessment age groups from adult to pediatric and neonatal. The device is for providing thermal images of the human body. This device is intended for use by qualified healthcare personnel who are trained in its use. The system is not intended for absolute temperature measurements. The system is not intended to be used as a thermometry device.

Source page: https://510kreport.com/device/K212412
Methodology: https://510kreport.com/methodology