Class Class II

Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) (K242499)

K242499 2025-01-06 Traditional
Home/ Devices/ Digital Radiography X-ray System…

Description

Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) by Shenzhen Sontu Medical Imaging Equipment Co., Ltd., an FDA 510(k) cleared radiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK242499
Clearance Date2025-01-06
Clearance TypeTraditional
Product CodeKPR
Regulation Number892.1680

Categories

Need More Information?

Contact the manufacturer or request a quote for this device.

Request Quote

Predicate lineage for K242499

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) (K242499) cites 2 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K220919MULTIX Impact ESiemens Medical Solutions USA, Inc.2022
K213700MULTIX Impact, MULTIX Impact CSiemens Medical Solutions USA, Inc.2021

Trace the full predicate network for K242499

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

Scroll to Top