510(k) K241389
K241389 is an FDA 510(k) premarket notification submitted by Infrascan, Inc. for the device "Infrascanner Model 2500 (Model 2500)". The FDA issued a decision of Substantially Equivalent on December 12, 2024. The device falls under product code OPT (Infrared Hematoma Detector), a Class II device regulated under 21 CFR 882.1935. Infrascan, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 12, 2024
- Date Received
- May 15, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Infrared Hematoma Detector
- Device Class
- Class II
- Regulation Number
- 882.1935
- Review Panel
- NE
- Submission Type
To employ near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.