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FDA 510(k)

MTHF-9R MOBIL C-ARM IMAGE INTENSIFIER UNIT

K-Number: K900193 · 1990-05-09

ApplicantImt America, Inc.
Decision Date1990-05-09
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MTHF-9R MOBIL C-ARM IMAGE INTENSIFIER UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Imt America, Inc.. It received FDA 510(k) clearance on 1990-05-09 under 510(k) number K900193. 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 MTHF-9R MOBIL C-ARM IMAGE INTENSIFIER UNIT?

MTHF-9R MOBIL C-ARM IMAGE INTENSIFIER UNIT is a medical device that received FDA 510(k) clearance on 1990-05-09. The listed applicant is Imt America, Inc.. The 510(k) number is K900193.

When did MTHF-9R MOBIL C-ARM IMAGE INTENSIFIER UNIT receive FDA 510(k) clearance?

MTHF-9R MOBIL C-ARM IMAGE INTENSIFIER UNIT received FDA 510(k) clearance on 1990-05-09, under 510(k) number K900193.

Who is the listed applicant for MTHF-9R MOBIL C-ARM IMAGE INTENSIFIER UNIT?

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

What is the FDA product code for MTHF-9R MOBIL C-ARM IMAGE INTENSIFIER UNIT?

The FDA product code for MTHF-9R MOBIL C-ARM IMAGE INTENSIFIER UNIT 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.

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Other records listing Imt America, 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.

K903921MTE-T RADIOGRPHIC/TOMOGRAPHIC ELEVATING TABLEK901654MTT 90 UNIVERSAL REMOTE-CONTROLLED X-RAY TABLEK903422MT-15 RADIOGRAPHIC/FLUOROSCOPIC TILT TABLEK900194MTHF-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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