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FDA 510(k)

O-ARM IMAGING SYSTEM

K-Number: K060344 · 2006-03-29

ApplicantBreakaway Imaging, LLC
Decision Date2006-03-29
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

O-ARM IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Breakaway Imaging, LLC. It received FDA 510(k) clearance on 2006-03-29 under 510(k) number K060344. 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 O-ARM IMAGING SYSTEM?

O-ARM IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2006-03-29. The listed applicant is Breakaway Imaging, LLC. The 510(k) number is K060344.

When did O-ARM IMAGING SYSTEM receive FDA 510(k) clearance?

O-ARM IMAGING SYSTEM received FDA 510(k) clearance on 2006-03-29, under 510(k) number K060344.

Who is the listed applicant for O-ARM IMAGING SYSTEM?

The FDA 510(k) record lists Breakaway Imaging, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for O-ARM IMAGING SYSTEM?

The FDA product code for O-ARM IMAGING SYSTEM is OXO.

Related Clinical Trials

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.

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Other records listing Breakaway Imaging, LLC as applicant

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.

K050996O-ARM IMAGING SYSTEM

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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