Faxitron Bioptics Speciemen Radiography System

FDA 510(k) K170786 · Faxitron Bioptics, LLC

Substantially Equivalent

510(k) numberK170786

Submission

Device name
Faxitron Bioptics Speciemen Radiography System
Applicant
Faxitron Bioptics, LLC
Tucson, AZ, US
Received
March 16, 2017
Decision date
July 18, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MWP – Cabinet, X-Ray System
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1680
Specialty
Radiology

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K230140TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)MWP · Traditional Compai Healthcare (Suzhou) Co.,Ltd04/24/2023SE
K230136TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)MWP · Traditional Compai Healthcare (Suzhou) Co.,Ltd04/24/2023SE
K213691Solas ORMWP · Traditional Cirdan Imaging, Ltd.12/22/2021SE
K210955Kubtec Mozart Supra (XPERT 84) Radiography SystemMWP · Special Kub Technologies, Inc.09/20/2021SE
K210957Kubec Xpert 80 Radiography SystemMWP · Special Kub Technologies, Inc.08/31/2021SE
K210956Kubtec Mozart (XPERT42)MWP · Special Kub Technologies, Inc.08/31/2021SE
K202713TrueView 100 ProMWP · Traditional Compai Healthcare (Shenzhen) Co.,Ltd11/18/2020SE
K200756Kubtec Mozart SupraMWP · Traditional Kub Technologies, Inc.06/12/2020SE
K192939Volumetric Specimen ImagerMWP · Traditional Clarix Imaging12/27/2019SE
K193317CoreLite X-Ray Specimen CabinetMWP · Traditional Cirdan Imaging Limited12/13/2019SE

More from Cirdan Imaging Limited

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K183142PathVisionXLMWP · Traditional 03/14/2019SE
K173309Faxitron VisionCTMWP · Traditional 05/09/2018SE
K153583BioVision PlusMWP · Special 04/01/2016SE
K122428Faxitron Specien Radiography SystemMWP · Traditional 09/25/2012SE

Questions and answers

When was Faxitron Bioptics Speciemen Radiography System cleared by the FDA?

Faxitron Bioptics Speciemen Radiography System (K170786) received a 510(k) decision of Substantially Equivalent on July 18, 2017, 124 days after the submission was received.

What is the product code of K170786?

The FDA product code is MWP – Cabinet, X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1680.