FDA 510(k)

NDR+/DIVA-D

K-Number: K053029 · 2006-01-06

Decision Date2006-01-06

Product CodeMQB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

NDR+/DIVA-D is the device name listed in this FDA 510(k) record. The listed applicant is Nical Spa. It received FDA 510(k) clearance on 2006-01-06 under 510(k) number K053029. 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 NDR+/DIVA-D?

NDR+/DIVA-D is a medical device that received FDA 510(k) clearance on 2006-01-06. The listed applicant is Nical Spa. The 510(k) number is K053029.

When did NDR+/DIVA-D receive FDA 510(k) clearance?

NDR+/DIVA-D received FDA 510(k) clearance on 2006-01-06, under 510(k) number K053029.

Who is the listed applicant for NDR+/DIVA-D?

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

What is the FDA product code for NDR+/DIVA-D?

The FDA product code for NDR+/DIVA-D 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.