Infrared Hematoma Detector
The Infrared Hematoma Detector (product code OPT) is a Class 2 neurological device regulated under 21 CFR 882.1935, reviewed by the Neurology panel and cleared via 510(k). It employs near-infrared spectroscopy to evaluate suspected brain hematomas non-invasively, providing clinicians with information to aid in the rapid assessment of potential intracranial bleeding. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- OPT
- Device Class
- FDA class 2
- Regulation Number
- 882.1935
- Medical Specialty
- Ophthalmic
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
Definition
To employ near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K241389 | Infrascanner Model 2500 (Model 2500) | Dec 12, 2024 | Substantially Equivalent | Infrascan, Inc. |
| K211617 | Infrascanner | Feb 09, 2022 | Substantially Equivalent | Infrascan, Inc. |
| K200203 | Infrascanner | Jul 10, 2020 | Substantially Equivalent | Infrascan, Inc. |
| K120949 | INFRASCANNER | Jan 11, 2013 | Substantially Equivalent | Infrascan, Inc. |
| DEN100002 | INFRASCANNER, MODEL 1000 | Dec 13, 2011 | Unknown | Infrascan, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.