AccuCTP

FDA 510(k) K220663 · ArteryFlow Technology Co., Ltd.

Substantially Equivalent

510(k) numberK220663

Submission

Device name
AccuCTP
Applicant
ArteryFlow Technology Co., Ltd.
Hangzhou City, CN
Received
March 7, 2022
Decision date
November 22, 2022
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

510(k)DeviceApplicantDecision
K2620603D-RD-SLLZ · Traditional Radiopharmaceutical Imaging & Dosimetry, LLC09/04/2026SE
K261500KBA3D (v2.4.0)LLZ · Traditional S.M.A.I.O08/17/2026SE
K262449AdvaViewLLZ · Special Advahealth Solutions, LLC08/14/2026SE
K261916NeuroQuant PETLLZ · Traditional Cortechs Labs, Inc.08/12/2026SE
K260936RadioViewAILLZ · Traditional Neurocareai, Inc. (Dba Savelife.Ai)07/31/2026SE
K260588Cleerly LABSLLZ · Traditional Cleerly, Inc.07/29/2026SE
K262462TheraSphere 360™ Y-90 Management PlatformLLZ · Special Boston Scientific Corporation07/24/2026SE
K262143ImageGrid StreamVueLLZ · Traditional Candelis, Inc.07/23/2026SE
K260500ResolutionMDLLZ · Traditional ResolutionMD, Inc.07/21/2026SE
K262120Avara ViewerLLZ · Traditional Avara Software07/10/2026SE

More from Avara Software

510(k)DeviceDecision
K231353AccuCTP ProLLZ · Special 09/14/2023SE
K230303AccuFFRangio PlusQHA · Special 03/02/2023SE
K221711AccuICASQHA · Traditional 02/28/2023SE
K213838AneuGuidePZO · Traditional 06/01/2022SE
K210093AccuFFRangioQHA · Traditional 09/10/2021SE

Questions and answers

When was AccuCTP cleared by the FDA?

AccuCTP (K220663) received a 510(k) decision of Substantially Equivalent on November 22, 2022, 260 days after the submission was received.

What is the product code of K220663?

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