# K200203: Infrascanner

- Pathway: 510(k) (Traditional)
- Applicant: Infrascan, Inc.
- Decided: Jul 10, 2020 after 164 days
- Product code: OPT (Infrared Hematoma Detector)
- Device class: 2
- Regulation: 21 CFR 882.1935
- 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 DEN100002 (2011). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120949: Infrascanner, Infrascan, Inc. (2013) Summary page 4.

## Most influential descendants
- K211617: Infrascanner (2022), 1 descendant of its own
- K241389: Infrascanner Model 2500 (Model 2500) (2024), 0 descendants of its own

## Indications for use
The Infrascanner is indicated for the detection of traumatic supratentorial hematomas of greater than 3.5 mL in volume that are less than 2.5 cm from the brain surface, as an adjunctive device to the clinical evaluation in the acute hospital setting of patients 18 years old or greater with suspected traumatic supratentorial intracranial hematoma. The device is indicated to assess patients for CT scans but should not serve as a substitute for these scans. The Infrascanner is indicated for use by Physicians, or under the direction of a physician, who has been trained in the use of the device.

Source page: https://510kreport.com/device/K200203
Methodology: https://510kreport.com/methodology