MasteRad MiniX Mobile Digital Imaging System (Mini-X)

Q: What is the product code of K242731?

The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.

FDA 510(k) K242731 · Medicatech USA, Inc.

Substantially Equivalent

510(k) numberK242731

Submission

Device name: MasteRad MiniX Mobile Digital Imaging System (Mini-X)
Applicant: Medicatech USA, Inc.
Irvine, CA, US
Received: September 10, 2024
Decision date: May 16, 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: OWB – Interventional Fluoroscopic X-Ray System
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.1650
Specialty: Radiology

Interventional fluoroscopy

Other 510(k)s with product code OWB

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K261413	Extron 3;EXTRON 6OWB · Traditional	DRTECH Corporation	08/19/2026SE
K254205	Zenition 30OWB · Traditional	Philips Medical Systems Nederland B.V.	08/07/2026SE
K260607	Shield System (Siemens 30x40)OWB · Special	Radiaction , Ltd.	07/31/2026SE
K253670	SmartCT (R3.0 (L10))OWB · Abbreviated	Philips Medical Systems B.V.	07/10/2026SE
K252735	C-beamOWB · Traditional	Pulmera, Inc.	05/22/2026SE
K252503	Intelligent NROWB · Traditional	Canon, Inc.	04/30/2026SE
K254173	ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoOWB · Traditional	Siemens Medical Solutions USA, Inc.	04/24/2026SE
K253752	ARTIS genio floor; ARTIS icono.explore floorOWB · Traditional	Siemens Medical Solutions USA, Inc.	04/23/2026SE
K252229	Belliger AceOWB · Traditional	Genoray Co., Ltd.	04/02/2026SE

More from Genoray Co., Ltd.

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K143257	KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic SystemKPR · Traditional	02/06/2015SE
K130377	Krystalrad New Seriesdigital Radiographic Portable Retrofit SystemMQB · Special	05/17/2013SE
K112132	Krystalrad 660 Digital Radiographic Portable Retrofit SystemMQB · Traditional	11/18/2011SE
K102285	Krystalrad (ATAL8)KPR · Traditional	01/03/2011SE
K102284	Krystalrad 560 (Flaatz 560)KPR · Traditional	01/03/2011SE
K082798	Digital Diagnostic X-Ray System, Models Mak 1500, Mak 2000 and Mak 3000KPR · Special	10/28/2008SE
K080582	Medicatech, Model DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FaKPR · Traditional	05/15/2008SE

Questions and answers

When was MasteRad MiniX Mobile Digital Imaging System (Mini-X) cleared by the FDA?

MasteRad MiniX Mobile Digital Imaging System (Mini-X) (K242731) received a 510(k) decision of Substantially Equivalent on May 16, 2025, 248 days after the submission was received.

What is the product code of K242731?

The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.