Class Class II
A1417MCW/A1717MCW/F1417MCW (K223930)
Description
A1417MCW/A1717MCW/F1417MCW by H&abyz Co., Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223930
Clearance Date2023-03-06
Clearance TypeTraditional
Product CodeMQB
Regulation Number892.1680
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223930
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. A1417MCW/A1717MCW/F1417MCW (K223930) cites 1 predicate device and is itself cited by 3 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213497 | ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) | H&abyz Co., Ltd. | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250750 | INNOVISION-P5 | Dk Medical Systems Co., Ltd. | 2025 |
| K242015 | TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) | DRGEM Corporation | 2024 |
| K241346 | IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ra... | Aspen Imaging Healthcare, Inc. | 2024 |
Trace the full predicate network for K223930
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.