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FDA 510(k)

SKANRAD 400

K-Number: K220518 · 2022-04-01

ApplicantSkanray Technologies Limited
Decision Date2022-04-01
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SKANRAD 400 is a medical device manufactured by Skanray Technologies Limited. It received FDA 510(k) clearance on 2022-04-01 under approval number K220518. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SKANRAD 400?

SKANRAD 400 is a medical device that received FDA 510(k) clearance on 2022-04-01. It is manufactured by Skanray Technologies Limited. The 510(k) number is K220518.

When was SKANRAD 400 approved by the FDA?

SKANRAD 400 received FDA 510(k) clearance on 2022-04-01, under approval number K220518.

What company makes SKANRAD 400?

SKANRAD 400 is manufactured by Skanray Technologies Limited.

What is the FDA product code for SKANRAD 400?

The FDA product code for SKANRAD 400 is KPR.

Other Devices by Skanray Technologies Limited

K212940Skanmobile, Skanmobile-Dr K231761PodSKAN HF Diagnostic X-ray System K251893SKAN C PULSAR

Related Devices (Code: KPR)

K163203Carestream DRX-EvolutionCarestream Health, Inc. K163115GC70Samsung Electronics Co., Ltd. K152813FS-500DDR Medical Radiographic X-Ray SystemOrich Medical Equipment (Tianjin) Co., Ltd. K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc. K161937CuattroDRCuattro, LLC K162224ArtPix Mobile EZ2GOCmt Medical Technologies, Ltd.

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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