Diagnostic X-ray System/PLX5200A

FDA 510(k) K212134 · Nanjing Perlove Medical Equipment Co., Ltd.

Substantially Equivalent

510(k) numberK212134

Submission

Device name
Diagnostic X-ray System/PLX5200A
Applicant
Nanjing Perlove Medical Equipment Co., Ltd.
Nanjing, CN
Received
July 8, 2021
Decision date
August 25, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IZL – System, X-Ray, Mobile
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1720
Specialty
Radiology

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Questions and answers

When was Diagnostic X-ray System/PLX5200A cleared by the FDA?

Diagnostic X-ray System/PLX5200A (K212134) received a 510(k) decision of Substantially Equivalent on August 25, 2021, 48 days after the submission was received.

What is the product code of K212134?

The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.