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FDA 510(k)

KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260

K-Number: K073670 · 2008-01-25

ApplicantOrex Computed Radiography, Ltd.
Decision Date2008-01-25
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260 is the device name listed in this FDA 510(k) record. The listed applicant is Orex Computed Radiography, Ltd.. It received FDA 510(k) clearance on 2008-01-25 under 510(k) number K073670. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260?

KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260 is a medical device that received FDA 510(k) clearance on 2008-01-25. The listed applicant is Orex Computed Radiography, Ltd.. The 510(k) number is K073670.

When did KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260 receive FDA 510(k) clearance?

KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260 received FDA 510(k) clearance on 2008-01-25, under 510(k) number K073670.

Who is the listed applicant for KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260?

The FDA 510(k) record lists Orex Computed Radiography, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260?

The FDA product code for KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260 is MQB.

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Other records listing Orex Computed Radiography, Ltd. 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.

K032654PORT CASSETTEK003256PCCR DIGITAL IMAGING DEVICE

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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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