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FDA 510(k)

ORTHOSCAN, ORTHOSCAN HD

K-Number: K051754 · 2005-08-09

ApplicantOrthoscan, Inc.
Decision Date2005-08-09
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ORTHOSCAN, ORTHOSCAN HD is the device name listed in this FDA 510(k) record. The listed applicant is Orthoscan, Inc.. It received FDA 510(k) clearance on 2005-08-09 under 510(k) number K051754. 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, ORTHOSCAN HD?

ORTHOSCAN, ORTHOSCAN HD is a medical device that received FDA 510(k) clearance on 2005-08-09. The listed applicant is Orthoscan, Inc.. The 510(k) number is K051754.

When did ORTHOSCAN, ORTHOSCAN HD receive FDA 510(k) clearance?

ORTHOSCAN, ORTHOSCAN HD received FDA 510(k) clearance on 2005-08-09, under 510(k) number K051754.

Who is the listed applicant for ORTHOSCAN, ORTHOSCAN HD?

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, ORTHOSCAN HD?

The FDA product code for ORTHOSCAN, ORTHOSCAN HD 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-ArmK113708ORTHOSCAN MOBILE DI MINI C-ARM

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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