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FDA 510(k)

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

K-Number: K242499 · 2025-01-06

Decision Date2025-01-06
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Sontu Medical Imaging Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-01-06 under 510(k) 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. The listed applicant is Shenzhen Sontu Medical Imaging Equipment Co., Ltd.. The 510(k) number is K242499.

When did Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) receive FDA 510(k) clearance?

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

Who is the listed applicant for Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))?

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

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 Devices (Code: KPR)

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.

Official Source

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