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FDA 510(k)

Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))

K-Number: K242499 · 2025-01-06

ApplicantShenzhen Sontu Medical Imaging Equipment Co., Ltd.
Decision Date2025-01-06
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) is a medical device manufactured by Shenzhen Sontu Medical Imaging Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-01-06 under approval number K242499. 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 Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))?

Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) is a medical device that received FDA 510(k) clearance on 2025-01-06. It is manufactured by Shenzhen Sontu Medical Imaging Equipment Co., Ltd.. The 510(k) number is K242499.

When was Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) approved by the FDA?

Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) received FDA 510(k) clearance on 2025-01-06, under approval number K242499.

What company makes Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))?

Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) is manufactured by Shenzhen Sontu Medical Imaging Equipment Co., Ltd..

What is the FDA product code for Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))?

The FDA product code for Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) is KPR.

Related Clinical Trials

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Related PubMed Literature

PMID: 33371797 Developing a Qualification and Verification Strategy for Digital Tissue Image Analysis in Toxicological Pathology. Toxicologic pathology (2021)

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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