510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K120949Substantially Equivalent

Infrascanner

Infrascan, Inc., Philedelphia PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120949 is the FDA 510(k) clearance record for INFRASCANNER, a class II device, cleared for Infrascan, Inc. on under FDA product code OPT (Infrared Hematoma Detector). FDA's definition for product code OPT reads: "To employ near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas". FDA records list 5 510(k) clearances for Infrascan, Inc., from to . As of , FDA records show no recalls naming K120949.

Clearance record

Decision date
Received
(287 days to decision)
Product code
OPT Infrared Hematoma Detector
Regulation
21 CFR 882.1935
Device class
Class II
Review panel
Ophthalmic
Applicant
Infrascan, Inc. 1835 Market St., 29th Floor, Philedelphia PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OPT

Trailing 12 months

FDA records hold no clearances under product code OPT in the trailing twelve months.

FDA records show no clearances under product code OPT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OPT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260