Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Neurological Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1935](/submissions/OP/subpart-b%E2%80%94neurological-diagnostic-devices/882.1935) → OPT — Infrared Hematoma Detector

# OPT · Infrared Hematoma Detector

_Ophthalmic · 21 CFR 882.1935 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94neurological-diagnostic-devices/OPT

## Overview

- **Product Code:** OPT
- **Device Name:** Infrared Hematoma Detector
- **Regulation:** [21 CFR 882.1935](/submissions/OP/subpart-b%E2%80%94neurological-diagnostic-devices/882.1935)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

A Near Infrared (NIR) Brain Hematoma Detector is a noninvasive device that employs near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.

## Classification Rationale

Class II (special controls). The special controls for this device are:

## Special Controls

In addition to the general controls of the Act, the Infrascanner is subject to the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) The sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;
(2) The labeling must include specific instructions and the clinical training needed for the safe use of this device;
(3) Appropriate analysis/testing should validate electromagnetic compatibility (EMC), electrical safety, and battery characteristics;
(4) Performance data should validate accuracy and precision and safety features;
(5) Any elements of the device that may contact the patient should be demonstrated to be biocompatible; and,
(6) Appropriate software verification, validation, and hazard analysis should be performed.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K241389](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94neurological-diagnostic-devices/OPT/K241389.md) | Infrascanner Model 2500 (Model 2500) | Infrascan, Inc. | Dec 12, 2024 | SESE |
| [K211617](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94neurological-diagnostic-devices/OPT/K211617.md) | Infrascanner | Infrascan, Inc. | Feb 9, 2022 | SESE |
| [K200203](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94neurological-diagnostic-devices/OPT/K200203.md) | Infrascanner | Infrascan, Inc. | Jul 10, 2020 | SESE |
| [K120949](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94neurological-diagnostic-devices/OPT/K120949.md) | INFRASCANNER | Infrascan, Inc. | Jan 11, 2013 | SESE |
| [DEN100002](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94neurological-diagnostic-devices/OPT/DEN100002.md) | INFRASCANNER, MODEL 1000 | Infrascan, Inc. | Dec 13, 2011 | DENG |

## Top Applicants

- Infrascan, Inc. — 5 clearances

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94neurological-diagnostic-devices/OPT](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94neurological-diagnostic-devices/OPT)

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