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FDA 510(k)

AccuCheck

K-Number: K223834 · 2023-07-20

ApplicantManteia Technologies Co., Ltd.
Decision Date2023-07-20
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AccuCheck is the device name listed in this FDA 510(k) record. The listed applicant is Manteia Technologies Co., Ltd.. It received FDA 510(k) clearance on 2023-07-20 under 510(k) number K223834. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AccuCheck?

AccuCheck is a medical device that received FDA 510(k) clearance on 2023-07-20. The listed applicant is Manteia Technologies Co., Ltd.. The 510(k) number is K223834.

When did AccuCheck receive FDA 510(k) clearance?

AccuCheck received FDA 510(k) clearance on 2023-07-20, under 510(k) number K223834.

Who is the listed applicant for AccuCheck?

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

What is the FDA product code for AccuCheck?

The FDA product code for AccuCheck is IYE.

Other records listing Manteia Technologies 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.

K251351AccuContour 4.0K250780ARTAssistantK250696AccuCheckK223724MOZI TPSK221706AccuContour

Related Devices (Code: IYE)

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.

K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser ApplikationenK260792AerFrame Patient Immobilization System (AFPIS)Stabilix, LLCK252258VERIQA RT EPID 3DPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. PychlaK253962ClearCheck (RADCC V2.7)Radformation, 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.

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