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FDA 510(k)

RFA-1717DIG, RFA-1717DIC

K-Number: K212051 · 2021-08-25

ApplicantAstel, Inc.
Decision Date2021-08-25
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RFA-1717DIG, RFA-1717DIC is the device name listed in this FDA 510(k) record. The listed applicant is Astel, Inc.. It received FDA 510(k) clearance on 2021-08-25 under 510(k) number K212051. 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 RFA-1717DIG, RFA-1717DIC?

RFA-1717DIG, RFA-1717DIC is a medical device that received FDA 510(k) clearance on 2021-08-25. The listed applicant is Astel, Inc.. The 510(k) number is K212051.

When did RFA-1717DIG, RFA-1717DIC receive FDA 510(k) clearance?

RFA-1717DIG, RFA-1717DIC received FDA 510(k) clearance on 2021-08-25, under 510(k) number K212051.

Who is the listed applicant for RFA-1717DIG, RFA-1717DIC?

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

What is the FDA product code for RFA-1717DIG, RFA-1717DIC?

The FDA product code for RFA-1717DIG, RFA-1717DIC 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) 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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