BONX805

FDA 510(k) K243864 · Bontech Co., Ltd.

Substantially Equivalent

510(k) numberK243864

Submission

Device name
BONX805
Applicant
Bontech Co., Ltd.
Suwon-Si, KR
Received
December 17, 2024
Decision date
September 12, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IZL – System, X-Ray, Mobile
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1720
Specialty
Radiology

Other 510(k)s with product code IZL

510(k)DeviceApplicantDecision
K260236XliteIZL · Traditional Gemss Healthcare Co., Ltd.08/03/2026SE
K253058Portable DR Imaging SystemIZL · Traditional Shantou Institute of Ultrasonic Instruments Co.…06/18/2026SE
K260085RAYMO Mobile X-ray System (Model: RAYMO)IZL · Traditional DRGEM Corporation05/14/2026SE
K253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemIZL · Traditional Carestream Health03/11/2026SE
K253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)IZL · Traditional Poskom Co., Ltd.02/23/2026SE
K250976Airbile-100IZL · Traditional Poskom Co., Ltd.12/19/2025SE
K251710Mobile X-ray unit (!M1)IZL · Traditional Solutions For Tomorrow AB10/24/2025SE
K251443PromoIZL · Traditional DRGEM Corporation08/22/2025SE
K251223HnX-P1, HnX-PBIZL · Traditional H&abyz Co., Ltd.08/04/2025SE
K250597REMEX Xcam6IZL · Traditional Remedi, Inc.07/31/2025SE

More from Remedi, Inc.

510(k)DeviceDecision
K200787BSD3543WMQB · Special 04/23/2020SE
K171485BSD4343R Digital Flat Panel X-ray DetectorMQB · Special 06/21/2017SE
K162487BSD3543 Digital Flat Panel X-ray DetectorMQB · Special 10/14/2016SE
K160204BSD4343 Digital Flat Panel X-ray DetectorMQB · Traditional 06/09/2016SE

Questions and answers

When was BONX805 cleared by the FDA?

BONX805 (K243864) received a 510(k) decision of Substantially Equivalent on September 12, 2025, 269 days after the submission was received.

What is the product code of K243864?

The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.