LV Liberty Vision Model 1 90Yttrium Brachytherapy Source

Q: What is the product code of K193602?

The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.

FDA 510(k) K193602 · Lv Liberty Vision Corporation

Substantially Equivalent

510(k) numberK193602

Submission

Device name: LV Liberty Vision Model 1 90Yttrium Brachytherapy Source
Applicant: Lv Liberty Vision Corporation
Portsmouth, NH, US
Received: December 23, 2019
Decision date: May 29, 2020
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: KXK – Source, Brachytherapy, Radionuclide
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.5730
Specialty: Radiology
Implant: Yes

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K180515	GammaTileKXK · Traditional	Isoray Medical, Inc.	07/06/2018SE
K171487	Sirius MRI Marker NSKXK · Traditional	C4 Imaging, LLC	08/25/2017SE

More from C4 Imaging, LLC

510(k)	Device	Decision
K163572	LV Liberty Vision Model 1 90 Yttrium Brachytherapy SourceKXK · Traditional	03/15/2017SE

Questions and answers

When was LV Liberty Vision Model 1 90Yttrium Brachytherapy Source cleared by the FDA?

LV Liberty Vision Model 1 90Yttrium Brachytherapy Source (K193602) received a 510(k) decision of Substantially Equivalent on May 29, 2020, 158 days after the submission was received.

What is the product code of K193602?

The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.