SaintView

FDA 510(k) K223660 · Inviz Corporation

Substantially Equivalent

510(k) numberK223660

Submission

Device name
SaintView
Applicant
Inviz Corporation
Gwangju, KR
Received
December 6, 2022
Decision date
August 14, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

Other 510(k)s with product code LLZ

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K262462TheraSphere 360™ Y-90 Management PlatformLLZ · Special Boston Scientific Corporation07/24/2026SE
K262143ImageGrid StreamVueLLZ · Traditional Candelis, Inc.07/23/2026SE
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Questions and answers

When was SaintView cleared by the FDA?

SaintView (K223660) received a 510(k) decision of Substantially Equivalent on August 14, 2023, 251 days after the submission was received.

What is the product code of K223660?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.