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FDA 510(k)

RADREX-I, SW V4.00 MODEL DRAD-3000E

K-Number: K122842 · 2012-10-09

ApplicantToshiba America Medical Systems, In.C
Decision Date2012-10-09
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADREX-I, SW V4.00 MODEL DRAD-3000E 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 2012-10-09 under 510(k) number K122842. 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 RADREX-I, SW V4.00 MODEL DRAD-3000E?

RADREX-I, SW V4.00 MODEL DRAD-3000E is a medical device that received FDA 510(k) clearance on 2012-10-09. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K122842.

When did RADREX-I, SW V4.00 MODEL DRAD-3000E receive FDA 510(k) clearance?

RADREX-I, SW V4.00 MODEL DRAD-3000E received FDA 510(k) clearance on 2012-10-09, under 510(k) number K122842.

Who is the listed applicant for RADREX-I, SW V4.00 MODEL DRAD-3000E?

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 RADREX-I, SW V4.00 MODEL DRAD-3000E?

The FDA product code for RADREX-I, SW V4.00 MODEL DRAD-3000E is MQB.

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Related Devices (Code: MQB)

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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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