Capri Applicator

FDA 510(k) K092822 · Vivaray, Inc.

Substantially Equivalent

510(k) numberK092822

Submission

Device name
Capri Applicator
Applicant
Vivaray, Inc.
Portola Valley, CA, US
Received
September 14, 2009
Decision date
November 3, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JAQ – System, Applicator, Radionuclide, Remote-Controlled
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5700
Specialty
Radiology

Other 510(k)s with product code JAQ

510(k)DeviceApplicantDecision
K262383LumenCare AzureJAQ · Special Nucletron B.V.07/24/2026SE
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K251037Rectal ApplicatorJAQ · Traditional Nucletron B.V.12/19/2025SE
K252884Guided Aarhus Applicator SetJAQ · Traditional Varian Medical Systems11/19/2025SE
K250299CT/ MR Tandem and Ovoid SetJAQ · Traditional Varian Medical Systems, Inc.05/09/2025SE
K250289Intracavitary/Interstitial SystemJAQ · Traditional Varian Medical Systems04/25/2025SE
K243939Titanium Flexible Geometry FSD Applicator Set (GM11013400)JAQ · Traditional Varian Medical Systems, Inc.03/03/2025SE
K241764Mould Probe MR SafeJAQ · Traditional Varian Medical Systems, Inc.01/10/2025SE
K242961Intraluminal Applicator SetJAQ · Traditional Varian Medical Systems11/26/2024SE
K243045“BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)JAQ · Special Braxx Biotech Co., Ltd.11/19/2024SE

Questions and answers

When was Capri Applicator cleared by the FDA?

Capri Applicator (K092822) received a 510(k) decision of Substantially Equivalent on November 3, 2009, 50 days after the submission was received.

What is the product code of K092822?

The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.