AccuCTP Pro

FDA 510(k) K231353 · ArteryFlow Technology Co., Ltd.

Substantially Equivalent

510(k) numberK231353

Submission

Device name
AccuCTP Pro
Applicant
ArteryFlow Technology Co., Ltd.
Hangzhou City, CN
Received
May 10, 2023
Decision date
September 14, 2023
Decision
Substantially Equivalent (SESE)
Type
Special 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

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Questions and answers

When was AccuCTP Pro cleared by the FDA?

AccuCTP Pro (K231353) received a 510(k) decision of Substantially Equivalent on September 14, 2023, 127 days after the submission was received.

What is the product code of K231353?

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