510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K090321Substantially Equivalent

Ric Conformal Source, Model 100

Ri Consultants, LLC, Hudson NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090321 is the FDA 510(k) clearance record for RIC CONFORMAL SOURCE, MODEL 100, a class II device, cleared for Ri Consultants, LLC on under FDA product code ONL (Conformal Brachytherapy Source). FDA's definition for product code ONL reads: "The intended use of the device is for the treatment of cancer by tempeorary intraoperative or surface irradiation. The device contains radioactive material with activity up to 200 mci and is indicated for treatment of temporary...". FDA records list one 510(k) clearance for Ri Consultants, LLC. As of , FDA records show no recalls naming K090321.

Clearance record

Decision date
Received
(107 days to decision)
Product code
ONL Conformal Brachytherapy Source
Regulation
21 CFR 892.5730
Device class
Class II
Review panel
Radiology
Applicant
Ri Consultants, LLC 1 Chagnon Ln., Hudson NH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ONL

Trailing 12 months

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

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