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FDA 510(k)

SHIMADZU MOBILE X-RAY SYSTEMS

K-Number: K940294 · 1994-03-16

ApplicantShimadzu Precision Instruments, Inc.
Decision Date1994-03-16
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SHIMADZU MOBILE X-RAY SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Precision Instruments, Inc.. It received FDA 510(k) clearance on 1994-03-16 under 510(k) number K940294. 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 MOBILE X-RAY SYSTEMS?

SHIMADZU MOBILE X-RAY SYSTEMS is a medical device that received FDA 510(k) clearance on 1994-03-16. The listed applicant is Shimadzu Precision Instruments, Inc.. The 510(k) number is K940294.

When did SHIMADZU MOBILE X-RAY SYSTEMS receive FDA 510(k) clearance?

SHIMADZU MOBILE X-RAY SYSTEMS received FDA 510(k) clearance on 1994-03-16, under 510(k) number K940294.

Who is the listed applicant for SHIMADZU MOBILE X-RAY SYSTEMS?

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

What is the FDA product code for SHIMADZU MOBILE X-RAY SYSTEMS?

The FDA product code for SHIMADZU MOBILE X-RAY SYSTEMS is OXO.

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Other records listing Shimadzu Precision Instruments, 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.

K890913SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENTK884598SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200K884477SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150BK875378SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSIONK882311SHIMADZU LATERAL C-ARM MH-31K881674SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TC

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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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