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FDA 510(k)

MOONRAY MOBILE C-ARM

K-Number: K013426 · 2002-03-26

ApplicantSimad S.R.L.
Decision Date2002-03-26
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MOONRAY MOBILE C-ARM is the device name listed in this FDA 510(k) record. The listed applicant is Simad S.R.L.. It received FDA 510(k) clearance on 2002-03-26 under 510(k) number K013426. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOONRAY MOBILE C-ARM?

MOONRAY MOBILE C-ARM is a medical device that received FDA 510(k) clearance on 2002-03-26. The listed applicant is Simad S.R.L.. The 510(k) number is K013426.

When did MOONRAY MOBILE C-ARM receive FDA 510(k) clearance?

MOONRAY MOBILE C-ARM received FDA 510(k) clearance on 2002-03-26, under 510(k) number K013426.

Who is the listed applicant for MOONRAY MOBILE C-ARM?

The FDA 510(k) record lists Simad S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOONRAY MOBILE C-ARM?

The FDA product code for MOONRAY MOBILE C-ARM is OXO.

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Related Devices (Code: OXO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253296Digital C-ARM with 3DAllengers Medical Systems LimitedK252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc.K253269OEC One CFDGe Hualun Medical Systems Co. , Ltd.K251004Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)Hefei Chimed Intelligent Machine Co., Ltd.K250587Orthoscan TAU Mini C-ArmZiehm-Orthoscan, Inc.K243452Orthoscan VERSA Mini C-ArmZiehm-Orthoscan, Inc.

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.

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