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FDA 510(k)

OMNIPRO I'MRT

K-Number: K031634 · 2003-08-29

ApplicantWellhofer Dosimetrie
Decision Date2003-08-29
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OMNIPRO I'MRT is the device name listed in this FDA 510(k) record. The listed applicant is Wellhofer Dosimetrie. It received FDA 510(k) clearance on 2003-08-29 under 510(k) number K031634. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNIPRO I'MRT?

OMNIPRO I'MRT is a medical device that received FDA 510(k) clearance on 2003-08-29. The listed applicant is Wellhofer Dosimetrie. The 510(k) number is K031634.

When did OMNIPRO I'MRT receive FDA 510(k) clearance?

OMNIPRO I'MRT received FDA 510(k) clearance on 2003-08-29, under 510(k) number K031634.

Who is the listed applicant for OMNIPRO I'MRT?

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

What is the FDA product code for OMNIPRO I'MRT?

The FDA product code for OMNIPRO I'MRT is IYE.

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 Wellhofer Dosimetrie 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.

K032594ONE DIMENSIONAL WATER PHANTOM, WP 1D

Related Devices (Code: IYE)

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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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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