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FDA 510(k)

MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR

K-Number: K052884 · 2005-10-26

ApplicantToshiba America Medical Systems, In.C
Decision Date2005-10-26
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba America Medical Systems, In.C. It received FDA 510(k) clearance on 2005-10-26 under 510(k) number K052884. 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 MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR?

MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR is a medical device that received FDA 510(k) clearance on 2005-10-26. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K052884.

When did MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR receive FDA 510(k) clearance?

MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR received FDA 510(k) clearance on 2005-10-26, under 510(k) number K052884.

Who is the listed applicant for MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR?

The FDA 510(k) record lists Toshiba America Medical Systems, In.C as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR?

The FDA product code for MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR is OWB.

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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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