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FDA 510(k)

FLAATZ 560

K-Number: K111583 · 2011-10-04

ApplicantDrtech Corp.
Decision Date2011-10-04
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FLAATZ 560 is the device name listed in this FDA 510(k) record. The listed applicant is Drtech Corp.. It received FDA 510(k) clearance on 2011-10-04 under 510(k) number K111583. 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 FLAATZ 560?

FLAATZ 560 is a medical device that received FDA 510(k) clearance on 2011-10-04. The listed applicant is Drtech Corp.. The 510(k) number is K111583.

When did FLAATZ 560 receive FDA 510(k) clearance?

FLAATZ 560 received FDA 510(k) clearance on 2011-10-04, under 510(k) number K111583.

Who is the listed applicant for FLAATZ 560?

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

What is the FDA product code for FLAATZ 560?

The FDA product code for FLAATZ 560 is MQB.

Related Clinical Trials

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.

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Other records listing Drtech 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.

K111655FLAATZ 760K102474FLAATZ 750EK091747FLAATZ 500K080064FLAATZ 750

Related Devices (Code: MQB)

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.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.

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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