C-Qual M Breastboard; Monarch Overhead Arm Positioner
K-Number: K211001 · 2021-05-20
Decision Date2021-05-20
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
C-Qual M Breastboard; Monarch Overhead Arm Positioner is a medical device manufactured by Medtec, Inc. Dba Civco Medical Solutions and Civco. It received FDA 510(k) clearance on 2021-05-20 under approval number K211001. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the C-Qual M Breastboard; Monarch Overhead Arm Positioner?
C-Qual M Breastboard; Monarch Overhead Arm Positioner is a medical device that received FDA 510(k) clearance on 2021-05-20. It is manufactured by Medtec, Inc. Dba Civco Medical Solutions and Civco. The 510(k) number is K211001.
When was C-Qual M Breastboard; Monarch Overhead Arm Positioner approved by the FDA?
C-Qual M Breastboard; Monarch Overhead Arm Positioner received FDA 510(k) clearance on 2021-05-20, under approval number K211001.
What company makes C-Qual M Breastboard; Monarch Overhead Arm Positioner?
C-Qual M Breastboard; Monarch Overhead Arm Positioner is manufactured by Medtec, Inc. Dba Civco Medical Solutions and Civco.
What is the FDA product code for C-Qual M Breastboard; Monarch Overhead Arm Positioner?
The FDA product code for C-Qual M Breastboard; Monarch Overhead Arm Positioner is IYE.
Related Devices (Code: IYE)
K162476Varian High Energy Linear AcceleratorVarian Medical Systems, Inc.
K161400ImagingRing SystemMedphoton GmbH
K162468ClearCheckRadformation
K162355Raycast MammoRx Carbon Fibre Breast BoardOrfit Industries NV
K162577Dosimetry Check Version 5 Release 1Math Resolutions, LLC
K162265CushionCast Moldable CushionsIzi Medical Products, LLC
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.