10 X 10 Vision

FDA 510(k) K091928 · Bioptics, Inc.

Substantially Equivalent

510(k) numberK091928

Submission

Device name
10 X 10 Vision
Applicant
Bioptics, Inc.
Tucson, AZ, US
Received
June 30, 2009
Decision date
June 16, 2010
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

Other 510(k)s with product code MWP

510(k)DeviceApplicantDecision
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

510(k)DeviceDecision
K091558Biovision Digital Specimen Radiography SystemMWP · Traditional 07/17/2009SE
K082432Core Vision Digital Specimen Radiography (DSR) SystemMWP · Traditional 11/21/2008SE
K052433Pixarray 100 Digital Specimen Radiography (DSR) SystemMWP · Traditional 10/18/2005SE

Questions and answers

When was 10 X 10 Vision cleared by the FDA?

10 X 10 Vision (K091928) received a 510(k) decision of Substantially Equivalent on June 16, 2010, 351 days after the submission was received.

What is the product code of K091928?

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