FDA 510(k)

ATAL-8

K-Number: K113812 · 2012-05-03

ApplicantAtlaim

Decision Date2012-05-03

Product CodeMQB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ATAL-8 is the device name listed in this FDA 510(k) record. The listed applicant is Atlaim. It received FDA 510(k) clearance on 2012-05-03 under 510(k) number K113812. 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 ATAL-8?

ATAL-8 is a medical device that received FDA 510(k) clearance on 2012-05-03. The listed applicant is Atlaim. The 510(k) number is K113812.

When did ATAL-8 receive FDA 510(k) clearance?

ATAL-8 received FDA 510(k) clearance on 2012-05-03, under 510(k) number K113812.

Who is the listed applicant for ATAL-8?

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

What is the FDA product code for ATAL-8?

The FDA product code for ATAL-8 is MQB.

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) Limited K250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, 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.