ADD— 510(k) K203188

Substantially Equivalent

H&abyz Co., Ltd.

FDA 510(k) clearance K203188 for ADD, Substantially Equivalent on 2021-03-12. Applicant: H&abyz Co., Ltd.. Device class: 2.

Clearance details

Applicant: H&abyz Co., Ltd.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2020-10-27
Decision date: 2021-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yongin-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQB

K253800 — 0909FCE, 0909FCE-HS2026-07-31
K260820 — VIVIX-S 4386W (FXRD-4386WA)2026-06-18
K252996 — Universal 1417PI2026-06-12
K252911 — Lux HD 2530 detector (Lux HD 2530)2025-10-09
K250211 — Yushan X-Ray Flat Panel Detector2025-07-22

More clearances from H&abyz Co., Ltd.

K251223 — HnX-P1, HnX-PB2025-08-04
K223930 — A1417MCW/A1717MCW/F1417MCW2023-03-06
K213497 — ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)2021-11-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.