DMX

FDA 510(k) K223550 · Del Medical, Inc.

Substantially Equivalent

510(k) numberK223550

Submission

Device name
DMX
Applicant
Del Medical, Inc.
Bloomingdale, IL, US
Received
November 25, 2022
Decision date
April 10, 2023
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KPR – System, X-Ray, Stationary
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1680
Specialty
Radiology

Other 510(k)s with product code KPR

510(k)DeviceApplicantDecision
K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS…KPR · Traditional DRTECH Corporation09/08/2026SE
K260488MULTIX Impact; MULTIX Impact CKPR · Traditional Siemens Medical Solutions USA, Inc.08/31/2026SE
K260481GC85AKPR · Traditional Samsung Electronics Co., Ltd.08/27/2026SE
K260482DRE DuoKPR · Traditional Jpi Healthcare Co, Ltd.06/15/2026SE
K253446AeroDR TX c02KPR · Traditional Dk Medical Systems Co., Ltd.04/10/2026SE
K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…KPR · Traditional Carestream Health01/20/2026SE
K252000uDR Arria & uDR ArisKPR · Traditional Shanghai United Imaging Healthcare Co., Ltd.11/26/2025SE
K251167uDR Aurora CXKPR · Traditional Shanghai United Imaging Healthcare Co., Ltd.09/19/2025SE
K250788Definium Tempo SelectKPR · Traditional Ge Hualun Medical Systems Co. , Ltd.08/28/2025SE
K250790Innovision-DxiiKPR · Traditional Dk Medical Systems Co., Ltd.08/01/2025SE

More from Dk Medical Systems Co., Ltd.

510(k)DeviceDecision
K173018MDR17 Mobile Direct Radiographic SystemIZL · Abbreviated 11/20/2017SE
K152767OTC12D Auto Radiographic SystemKPR · Abbreviated 12/14/2015SE
K140825Delworks DR SystemMQB · Traditional 07/17/2014SE

Questions and answers

When was DMX cleared by the FDA?

DMX (K223550) received a 510(k) decision of Substantially Equivalent on April 10, 2023, 136 days after the submission was received.

What is the product code of K223550?

The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.