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FDA 510(k)

SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200

K-Number: K043379 · 2005-02-17

ApplicantShimadzu Corp.
Decision Date2005-02-17
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200 is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Corp.. It received FDA 510(k) clearance on 2005-02-17 under 510(k) number K043379. 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 SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200?

SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200 is a medical device that received FDA 510(k) clearance on 2005-02-17. The listed applicant is Shimadzu Corp.. The 510(k) number is K043379.

When did SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200 receive FDA 510(k) clearance?

SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200 received FDA 510(k) clearance on 2005-02-17, under 510(k) number K043379.

Who is the listed applicant for SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200?

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

What is the FDA product code for SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200?

The FDA product code for SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200 is OXO.

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Other records listing Shimadzu Corp. 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.

K101039SHIMADZU COLLIMATOR R-300K101036SHIMADZU COLLIMATOR R-20JK090578SHIMADZU COLLIMATOR R-30HK090268SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTIONK080701SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTIONK072006DAR-9400F

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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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