BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)

Q: What is the product code of K243045?

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

FDA 510(k) K243045 · Braxx Biotech Co., Ltd.

Substantially Equivalent

510(k) numberK243045

Submission

Device name: BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)
Applicant: Braxx Biotech Co., Ltd.
Taipei City, TW
Received: September 27, 2024
Decision date: November 19, 2024
Decision: Substantially Equivalent (SESE)
Type: Special 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

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More from Varian Medical Systems, Inc.

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Questions and answers

When was BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) cleared by the FDA?

BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) (K243045) received a 510(k) decision of Substantially Equivalent on November 19, 2024, 53 days after the submission was received.

What is the product code of K243045?

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

BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)