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FDA 510(k)

Digital Intraoral X-ray Sensor

K-Number: K220277 · 2022-02-17

ApplicantShenzhen Xpectvision Technology Co., Ltd.
Decision Date2022-02-17
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Digital Intraoral X-ray Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Xpectvision Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-02-17 under 510(k) number K220277. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Digital Intraoral X-ray Sensor?

Digital Intraoral X-ray Sensor is a medical device that received FDA 510(k) clearance on 2022-02-17. The listed applicant is Shenzhen Xpectvision Technology Co., Ltd.. The 510(k) number is K220277.

When did Digital Intraoral X-ray Sensor receive FDA 510(k) clearance?

Digital Intraoral X-ray Sensor received FDA 510(k) clearance on 2022-02-17, under 510(k) number K220277.

Who is the listed applicant for Digital Intraoral X-ray Sensor?

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

What is the FDA product code for Digital Intraoral X-ray Sensor?

The FDA product code for Digital Intraoral X-ray Sensor is MUH.

Other records listing Shenzhen Xpectvision Technology 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.

K233914XVbeam2000

Related Devices (Code: MUH)

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.

K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687Cocoon Solo (DX-7020s)Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)VATECH Co., Ltd.K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, Inc.

Official Source

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