Chrysalis Intelligence · Sponsors · H&abyz Co., Ltd.

H&abyz Co., Ltd.

Yongin-Si, KR · 5 510(k) clearances

Total clearances
5
2020-01-31 → 2025-08-04
Last 12 months
0
Product codes
2
Most recent
2025-08-04
Name variants in FDA filings: H&abyz Co., Ltd. / H&Abyz
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Class II Radiology 4 2023-03-06
IZL System, X-Ray, Mobile Class II Radiology 1 2025-08-04
Filings

All 510(k) clearances (5)

Date K-number Device Code Class Specialty
2025-08-04 K251223 HnX-P1, HnX-PB IZL Class II Radiology
2023-03-06 K223930 A1417MCW/A1717MCW/F1417MCW MQB Class II Radiology
2021-11-15 K213497 ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) MQB Class II Radiology
2021-03-12 K203188 ADD MQB Class II Radiology
2020-01-31 K200018 HAD1717MC MQB Class II Radiology