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FDA 510(k)

A1417MCW/A1717MCW/F1417MCW

K-Number: K223930 · 2023-03-06

ApplicantH&abyz Co., Ltd.
Decision Date2023-03-06
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

A1417MCW/A1717MCW/F1417MCW is the device name listed in this FDA 510(k) record. The listed applicant is H&abyz Co., Ltd.. It received FDA 510(k) clearance on 2023-03-06 under 510(k) number K223930. 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 A1417MCW/A1717MCW/F1417MCW?

A1417MCW/A1717MCW/F1417MCW is a medical device that received FDA 510(k) clearance on 2023-03-06. The listed applicant is H&abyz Co., Ltd.. The 510(k) number is K223930.

When did A1417MCW/A1717MCW/F1417MCW receive FDA 510(k) clearance?

A1417MCW/A1717MCW/F1417MCW received FDA 510(k) clearance on 2023-03-06, under 510(k) number K223930.

Who is the listed applicant for A1417MCW/A1717MCW/F1417MCW?

The FDA 510(k) record lists H&abyz Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A1417MCW/A1717MCW/F1417MCW?

The FDA product code for A1417MCW/A1717MCW/F1417MCW is MQB.

Other records listing H&abyz Co., Ltd. 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.

K251223HnX-P1, HnX-PBK213497ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)K203188ADDK200018HAD1717MC

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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