# K211617: Infrascanner

- Pathway: 510(k) (Traditional)
- Applicant: Infrascan, Inc.
- Decided: Feb 9, 2022 after 259 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: 3 generations back to DEN100002 (2011). 3 ancestors in all.
1 later device descends 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.
- K200203: Infrascanner, Infrascan, Inc. (2020) Summary page 4.

## Most influential descendants
- 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 as small as 3.5mL and as deep as 2.5 cm from brain surface, but not both at the same time, as an adjunctive device to the clinical evaluation in the acute hospital setting of adult patients and pediatric patients aged 2 years and older 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 device should only be used to rule in subjects for the presence of hematoma, never to rule out. 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/K211617
Methodology: https://510kreport.com/methodology