510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN240047Unknown

Allix5

Clairity, Inc., Austin TX / Direct, Unknown
FDA source (opens on fda.gov)

DEN240047 is the FDA 510(k) clearance record for Allix5, a class II device, cleared for Clairity, Inc. on under FDA product code SEZ (Radiological Software Device To Predict Future Breast Cancer Risk). FDA's definition for product code SEZ reads: "A radiological software device to predict future breast cancer risk is a device that analyzes radiological images generated by breast imaging modalities and/or inputs derived from radiological images to provide qualified healthcare...". FDA records list one 510(k) clearance for Clairity, Inc. As of , FDA records show no recalls naming DEN240047.

Clearance record

Decision date
Received
(266 days to decision)
Product code
SEZ Radiological Software Device To Predict Future Breast Cancer Risk
Regulation
21 CFR 892.8500
Device class
Class II
Review panel
Radiology
Applicant
Clairity, Inc. 201 W 5th St., Suite 1500, Austin TX
Third party review
No

Clearances, product code SEZ

Trailing 12 months

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

FDA records show no clearances under product code SEZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SEZ, 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