510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K182641Substantially Equivalent

Sensus IORT System

Sensus Healthcare, Boca Raton FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182641 is the FDA 510(k) clearance record for Sensus IORT System, a class II device, cleared for Sensus Healthcare, Inc. on under FDA product code JAD (System, Therapeutic, X-Ray). FDA records list 7 510(k) clearances for Sensus Healthcare, Inc., from to . As of , FDA records show no recalls naming K182641.

Clearance record

Decision date
Received
(150 days to decision)
Product code
JAD System, Therapeutic, X-Ray
Regulation
21 CFR 892.5900
Device class
Class II
Review panel
Radiology
Applicant
Sensus Healthcare, Inc. 851 Broken Sound Pkwy. NW, Suite 215, Boca Raton FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JAD

Trailing 12 months
1 clearance under product code JAD in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JAD, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260