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FDA 510(k)

FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50

K-Number: K061361 · 2006-08-15

ApplicantFaxitron X-Ray Corp.
Decision Date2006-08-15
Product CodeMWP
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50 is the device name listed in this FDA 510(k) record. The listed applicant is Faxitron X-Ray Corp.. It received FDA 510(k) clearance on 2006-08-15 under 510(k) number K061361. The device is classified under product code MWP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50?

FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50 is a medical device that received FDA 510(k) clearance on 2006-08-15. The listed applicant is Faxitron X-Ray Corp.. The 510(k) number is K061361.

When did FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50 receive FDA 510(k) clearance?

FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50 received FDA 510(k) clearance on 2006-08-15, under 510(k) number K061361.

Who is the listed applicant for FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50?

The FDA 510(k) record lists Faxitron X-Ray Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50?

The FDA product code for FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50 is MWP.

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Other records listing Faxitron X-Ray Corp. 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.

K072557FAXITRON SPECIMEN RADIOGRAPHY SYSTEM, MODEL MX-20

Related Devices (Code: MWP)

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.

K230140TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)Compai Healthcare (Suzhou) Co.,LtdK230136TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)Compai Healthcare (Suzhou) Co.,LtdK213691Solas ORCirdan Imaging, Ltd.K210955Kubtec Mozart Supra (XPERT 84) Radiography SystemKub Technologies, Inc.K210956Kubtec Mozart (XPERT42)Kub Technologies, Inc.K210957Kubec Xpert 80 Radiography SystemKub Technologies, 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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