MECALL CLISIS SYSTEMS, Discovery RF180

Q: What is the product code of K173395?

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

FDA 510(k) K173395 · General Medical Merate S.P.A

Substantially Equivalent

510(k) numberK173395

Submission

Device name: MECALL CLISIS SYSTEMS, Discovery RF180
Applicant: General Medical Merate S.P.A
Seriate, IT
Received: October 30, 2017
Decision date: May 21, 2018
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: JAA – System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.1650
Specialty: Radiology

Other 510(k)s with product code JAA

510(k)	Device	Applicant	Decision
K253103	Nexus DRF Digital X-ray Imaging SystemJAA · Traditional	Varex Imaging Corporation	05/29/2026SE
K251650	Insight Enhanced DRF (EN-1002-01)JAA · Traditional	Imaging Engineering, LLC	09/16/2025SE
K242488	Soteria E-ViewJAA · Traditional	Omega Medical Imaging, LLC	01/06/2025SE
K242948	Adora DRFi (04550010)JAA · Traditional	Nrt X-Ray A/S	12/23/2024SE
K233380	TRIDENT Mobile Fluoroscopy SystemJAA · Traditional	Dornier Medtech America	06/26/2024SE
K233945	ProxiDiagnost N90 / Precision CRF (706110, 706400)JAA · Special	Philips Medical Systems Dmc GmbH	01/11/2024SE
K232910	CombiDiagnost R90JAA · Special	Philips Medical Systems Dmc GmbH	10/19/2023SE
K232526	XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5JAA · Special	Canon Medical Systems Corporation	09/12/2023SE
K220871	NautilusJAA · Special	Dornier Medtech America, Inc.	04/18/2022SE
K212890	Nyquist.IQJAA · Traditional	Omega Medical Imaging, LLC	12/13/2021SE

More from Omega Medical Imaging, LLC

510(k)	Device	Decision
K213081	CLISIS SYSTEMS, Discovery RF180IZF · Traditional	10/26/2021SE
K140380	Opera SwingJAA · Traditional	09/26/2014SE
K082243	Precision Rxi Analog and Digital X-Ray SystemsOWB · Traditional	11/07/2008SE
K041605	Precision Rxi Analog X-Ray SystemOWB · Traditional	06/30/2004SE
K881386	X-Ray Generating System TF 1000IZO · Traditional	07/08/1988SE
K827993	MTH C/A Mobile C Arm · Traditional	09/13/1982SE

Questions and answers

When was MECALL CLISIS SYSTEMS, Discovery RF180 cleared by the FDA?

MECALL CLISIS SYSTEMS, Discovery RF180 (K173395) received a 510(k) decision of Substantially Equivalent on May 21, 2018, 203 days after the submission was received.

What is the product code of K173395?

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