OPT · Infrared Hematoma Detector
Ophthalmic · 21 CFR 882.1935 · Class 2
Overview
| Product Code | OPT |
|---|---|
| Device Name | Infrared Hematoma Detector |
| Regulation | 21 CFR 882.1935 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
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 | Infrascanner Model 2500 (Model 2500) | Infrascan, Inc. | Dec 12, 2024 | SESE |
| K211617 | Infrascanner | Infrascan, Inc. | Feb 9, 2022 | SESE |
| K200203 | Infrascanner | Infrascan, Inc. | Jul 10, 2020 | SESE |
| K120949 | INFRASCANNER | Infrascan, Inc. | Jan 11, 2013 | SESE |
| DEN100002 | INFRASCANNER, MODEL 1000 | Infrascan, Inc. | Dec 13, 2011 | DENG |
Top Applicants
- Infrascan, Inc. — 5 clearances
