21 CFR 882.1935 — Infrared Hematoma Detector
Ophthalmic (OP) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1935
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:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| OPT | Infrared Hematoma Detector | 2 | 5 |
Special Controls
OPT — Infrared Hematoma Detector
In addition to the general controls of the Act, the Infrascanner is subject to the following special controls:
De Novo Order DEN100002
OPT — Infrared Hematoma Detector
*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.
eCFR
OPT — Infrared Hematoma Detector
(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.
Ecfr Llm
