Vios Central Station Monitor Software, Vios Central Server Software

Q: What is the product code of K173107?

The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.

FDA 510(k) K173107 · Vios Medical, Inc.

Substantially Equivalent

510(k) numberK173107

Submission

Device name: Vios Central Station Monitor Software, Vios Central Server Software
Applicant: Vios Medical, Inc.
St. Paul, MN, US
Received: September 29, 2017
Decision date: July 26, 2018
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: DXJ – Display, Cathode-Ray Tube, Medical
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.2450
Specialty: Cardiovascular

Other 510(k)s with product code DXJ

510(k)	Device	Applicant	Decision
K212003	ESSENZ Patient MonitorDXJ · Special	Livanova Deutschland, GmbH	11/10/2021SE
K212208	Philips IntelliVue GuardianSoftware (Rev. E.0X)DXJ · Traditional	Philips Medizin Systeme Boeblingen GmbH	09/30/2021SE
K201162	Essence 55SP Large Monitor SystemDXJ · Traditional	Shenyang Torch-Bigtide Digital Technology Co.…	08/27/2020SE
K180534	Philips IntelliVue GuardianSoftwareDXJ · Traditional	Philips Medizin Systeme Boeblingen GmbH	07/16/2018SE
K173381	Nexxis ORDXJ · Special	Barco N.V.	02/22/2018SE
K172969	Essence 55S Large Monitor SystemDXJ · Traditional	Shenyang Torch-Bigtide Digital Technology Co.…	01/26/2018SE
K170460	Sorin ConnectDXJ · Special	Sorin Group Deutschland GmbH	06/08/2017SE
K170537	Nexxis OR, NexxisDXJ · Special	Barco N.V.	04/21/2017SE
K161880	NIVR58-T kitDXJ · Special	Barco N.V.	03/14/2017SE
K161767	Philips IntelliVue GuardianSoftwareDXJ · Traditional	Philips Medizin Systeme Boeblingen GmbH	01/27/2017SE

More from Philips Medizin Systeme Boeblingen GmbH

510(k)	Device	Decision
K172586	Vios Monitoring System Model 2050DRT · Traditional	06/22/2018SE
K150992	Vios Monitoring SystemDRT · Traditional	12/16/2015SE

Questions and answers

When was Vios Central Station Monitor Software, Vios Central Server Software cleared by the FDA?

Vios Central Station Monitor Software, Vios Central Server Software (K173107) received a 510(k) decision of Substantially Equivalent on July 26, 2018, 300 days after the submission was received.

What is the product code of K173107?

The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.