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FDA 510(k)

Orthoscan VERSA Mini C-Arm

K-Number: K243452 · 2025-01-14

ApplicantZiehm-Orthoscan, Inc.
Decision Date2025-01-14
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Orthoscan VERSA Mini C-Arm is the device name listed in this FDA 510(k) record. The listed applicant is Ziehm-Orthoscan, Inc.. It received FDA 510(k) clearance on 2025-01-14 under 510(k) number K243452. 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 VERSA Mini C-Arm?

Orthoscan VERSA Mini C-Arm is a medical device that received FDA 510(k) clearance on 2025-01-14. The listed applicant is Ziehm-Orthoscan, Inc.. The 510(k) number is K243452.

When did Orthoscan VERSA Mini C-Arm receive FDA 510(k) clearance?

Orthoscan VERSA Mini C-Arm received FDA 510(k) clearance on 2025-01-14, under 510(k) number K243452.

Who is the listed applicant for Orthoscan VERSA Mini C-Arm?

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

What is the FDA product code for Orthoscan VERSA Mini C-Arm?

The FDA product code for Orthoscan VERSA Mini C-Arm is OXO.

Other records listing Ziehm-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.

K252579Orthoscan TAU MVP Mini C-Arm SystemK250587Orthoscan TAU 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.K240828OEC One ASDGe Hualun Medical Systems Co. , Ltd.

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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