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FDA 510(k)

ORTHOSCAN MOBILE DI MINI C-ARM

K-Number: K113708 · 2012-01-05

ApplicantOrthoscan, Inc.
Decision Date2012-01-05
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ORTHOSCAN MOBILE DI MINI C-ARM is the device name listed in this FDA 510(k) record. The listed applicant is Orthoscan, Inc.. It received FDA 510(k) clearance on 2012-01-05 under 510(k) number K113708. 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 ORTHOSCAN MOBILE DI MINI C-ARM?

ORTHOSCAN MOBILE DI MINI C-ARM is a medical device that received FDA 510(k) clearance on 2012-01-05. The listed applicant is Orthoscan, Inc.. The 510(k) number is K113708.

When did ORTHOSCAN MOBILE DI MINI C-ARM receive FDA 510(k) clearance?

ORTHOSCAN MOBILE DI MINI C-ARM received FDA 510(k) clearance on 2012-01-05, under 510(k) number K113708.

Who is the listed applicant for ORTHOSCAN MOBILE DI MINI C-ARM?

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

What is the FDA product code for ORTHOSCAN MOBILE DI MINI C-ARM?

The FDA product code for ORTHOSCAN MOBILE DI MINI C-ARM 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Orthoscan, Inc. 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.

K213113Orthoscan Tau Mini C-ArmK183220OrthoScan TAU Mini C-ArmK051754ORTHOSCAN, ORTHOSCAN HD

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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