Resona R9, Resona R9 Exp, Resona R9 Pro, Resona R9S, Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S, Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 7OB, Resona 7PRO, Imagyn 7, Resona Y Diagnostic Ultrasound System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K202785 ↗

FDA Product Code

IYN

Device Class

Class II

Regulation

21 CFR Part 892.1550

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)

  Class II

  FDA 510(k) K143195 Active Cleared 22 Dec 2014

• ViewMate Multi Ultrasound System

  Class II

  FDA 510(k) K222754 Active Cleared 9 Nov 2022

• Hypervisor Central Monitoring System (Including Telemetry Monitoring System, Tms-6016)

  Class II

  FDA 510(k) K132036 Active Cleared 1 Jul 2014

• Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System

  Class II

  FDA 510(k) K171233 Active Cleared 12 Sep 2017

• VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor

  Class II

  FDA 510(k) K221267 Active Cleared 15 Dec 2022

• Accutorr 7/VS-900 Vital Signs Monitor

  Class II

  FDA 510(k) K170712 Active Cleared 2 Aug 2017