Class Class II
ULTRA 1040 (K241996)
Description
ULTRA 1040 by Ecoray Co., Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241996
Clearance Date2025-04-18
Clearance TypeTraditional
Product CodeIZL
Regulation Number892.1720
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241996
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. ULTRA 1040 (K241996) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200637 | SR-8100 Portable X-ray Unit | Shantou Institute of Ultrasonic Ins... | 2020 |
| K200418 | VIVIX-S VW | Vieworks Co., Ltd. | 2020 |
Trace the full predicate network for K241996
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.