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FDA 510(k)

RADPRO ION

K-Number: K083725 · 2009-01-22

Decision Date2009-01-22
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADPRO ION is the device name listed in this FDA 510(k) record. The listed applicant is Virtual Imaging, Inc.. It received FDA 510(k) clearance on 2009-01-22 under 510(k) number K083725. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADPRO ION?

RADPRO ION is a medical device that received FDA 510(k) clearance on 2009-01-22. The listed applicant is Virtual Imaging, Inc.. The 510(k) number is K083725.

When did RADPRO ION receive FDA 510(k) clearance?

RADPRO ION received FDA 510(k) clearance on 2009-01-22, under 510(k) number K083725.

Who is the listed applicant for RADPRO ION?

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

What is the FDA product code for RADPRO ION?

The FDA product code for RADPRO ION is OWB.

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.

Other records listing Virtual Imaging, 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.

Related Devices (Code: OWB)

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.

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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