GR40CW— 510(k) K181631

Substantially Equivalent

Samsung Electronics Co., Ltd.

FDA 510(k) clearance K181631 for GR40CW, Substantially Equivalent on 2018-07-20. Applicant: Samsung Electronics Co., Ltd.. Device class: 2.

Clearance details

Applicant: Samsung Electronics Co., Ltd.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2018-06-20
Decision date: 2018-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-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 Samsung Electronics Co., Ltd.

K260481 — GC85A2026-08-27
K261187 — Hearing Aid Feature2026-07-31
K261011 — Sleep Apnea Feature (v2.0)2026-07-20
K242651 — GM852024-10-01
K242478 — GF85 (models GF85-3P, GF85-SP)2024-09-19

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