# H&abyz Co., Ltd.

- Location (FDA's records): Yongin-Si, KR
- FDA decisions: 5 (2020–2025): 5 510(k) clearances
- Names in FDA's records: H&abyz Co., Ltd. (4); H&Abyz (1)
- Product codes: MQB (4), IZL (1)
- 510(k) review time since 2016: median 66 days, against 48 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 7 (2 its own); citations of its devices by later devices: 3 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Samsung Electronics Co., Ltd.: 2 (https://510kreport.com/company/samsung-electronics)
- Konica Minolta Medical & Graphic, Inc.: 1 (https://510kreport.com/company/konica-minolta-medical-graphic)
- Philips Medical Systems Dmc GmbH: 1 (https://510kreport.com/company/philips-medical-systems-dmc)
- Minxray, Inc.: 1 (https://510kreport.com/company/minxray)

## Firms that cite its devices most
- Aspen Imaging Healthcare, Inc.: 1 (https://510kreport.com/company/aspen-imaging-healthcare)

## Its most-cited devices
- K223930: A1417MCW/A1717MCW/F1417MCW (2023), cited by 1
- K203188: ADD (2021), cited by 1
- K213497: ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) (2021), cited by 1

## Recent decisions
- K251223: HnX-P1, HnX-PB (Aug 4, 2025)
- K223930: A1417MCW/A1717MCW/F1417MCW (Mar 6, 2023)
- K213497: ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) (Nov 15, 2021)
- K203188: ADD (Mar 12, 2021)
- K200018: HAD1717MC (Jan 31, 2020)

Source page: https://510kreport.com/company/h-abyz