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FDA 510(k)

UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS

K-Number: K033577 · 2005-03-18

ApplicantMedlink Imaging
Decision Date2005-03-18
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Medlink Imaging. It received FDA 510(k) clearance on 2005-03-18 under 510(k) number K033577. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS?

UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS is a medical device that received FDA 510(k) clearance on 2005-03-18. The listed applicant is Medlink Imaging. The 510(k) number is K033577.

When did UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS receive FDA 510(k) clearance?

UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS received FDA 510(k) clearance on 2005-03-18, under 510(k) number K033577.

Who is the listed applicant for UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS?

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

What is the FDA product code for UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS?

The FDA product code for UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS is KPR.

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Related Devices (Code: KPR)

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

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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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