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FDA 510(k)

SMART RAD

K-Number: K003438 · 2001-07-03

ApplicantCmt Medical Technologies, Ltd.
Decision Date2001-07-03
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SMART RAD is the device name listed in this FDA 510(k) record. The listed applicant is Cmt Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2001-07-03 under 510(k) number K003438. 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 SMART RAD?

SMART RAD is a medical device that received FDA 510(k) clearance on 2001-07-03. The listed applicant is Cmt Medical Technologies, Ltd.. The 510(k) number is K003438.

When did SMART RAD receive FDA 510(k) clearance?

SMART RAD received FDA 510(k) clearance on 2001-07-03, under 510(k) number K003438.

Who is the listed applicant for SMART RAD?

The FDA 510(k) record lists Cmt Medical Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMART RAD?

The FDA product code for SMART RAD is MQB.

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Other records listing Cmt Medical Technologies, Ltd. as applicant

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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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