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FDA 510(k)

DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D

K-Number: K013608 · 2001-11-15

ApplicantToshiba America Medical Systems, In.C
Decision Date2001-11-15
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D 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 2001-11-15 under 510(k) number K013608. 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 DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D?

DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D is a medical device that received FDA 510(k) clearance on 2001-11-15. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K013608.

When did DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D receive FDA 510(k) clearance?

DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D received FDA 510(k) clearance on 2001-11-15, under 510(k) number K013608.

Who is the listed applicant for DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D?

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 DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D?

The FDA product code for DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D 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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