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FDA 510(k)

General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K)

K-Number: K220149 · 2022-04-19

ApplicantXera Medical Systems & Technology , Ltd.
Decision Date2022-04-19
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K) is a medical device manufactured by Xera Medical Systems & Technology , Ltd.. It received FDA 510(k) clearance on 2022-04-19 under approval number K220149. 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 General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K)?

General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K) is a medical device that received FDA 510(k) clearance on 2022-04-19. It is manufactured by Xera Medical Systems & Technology , Ltd.. The 510(k) number is K220149.

When was General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K) approved by the FDA?

General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K) received FDA 510(k) clearance on 2022-04-19, under approval number K220149.

What company makes General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K)?

General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K) is manufactured by Xera Medical Systems & Technology , Ltd..

What is the FDA product code for General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K)?

The FDA product code for General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K) is KPR.

Related Clinical Trials

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Related PubMed Literature

PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026) PMID: 40246726 [Brief Discussion on the General Requirements of Quality Management System of Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

Related Devices (Code: KPR)

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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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