Jlk-Pwi

FDA 510(k) K242709 · JLK, Inc.

Substantially Equivalent

510(k) numberK242709

Submission

Device name
Jlk-Pwi
Applicant
JLK, Inc.
Seoul, KR
Received
September 9, 2024
Decision date
November 4, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

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

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Questions and answers

When was Jlk-Pwi cleared by the FDA?

Jlk-Pwi (K242709) received a 510(k) decision of Substantially Equivalent on November 4, 2024, 56 days after the submission was received.

What is the product code of K242709?

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