Radiology · 510(k) · 2022
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
GE Medical Systems Ultrasound and Primary Care Diagnostics,. Cleared by FDA on 6 June 2022 under submission K220358, product code IYN (system, imaging, pulsed doppler, ultrasonic). What FDA's record says, in FDA's words.
Device record · K220358
- Device. Voluson Expert 22, Voluson Expert 20, Voluson Expert 18DEVICE
- Company. GE Medical Systems Ultrasound and Primary Care Diagnostics,COMPANY
- Decision. 6 June 2022, 510(k), substantially equivalent (traditional review); received 8 February 2022DECISION
- Panel. RadiologyPANEL
- Product code. IYN, System, Imaging, Pulsed Doppler, UltrasonicCODE
- Regulation. 21 CFR 892.1550, Class IIREG
- Source. FDA database entry · decision document (11 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
. • The systems are manufactured with materials which have been evaluated and found to be safe for the intended use of the device. • The systems have acoustic power levels which are below the applicable FDA limits. • The proposed Voluson Expert Series 22/20/18 and predicate Voluson E10 system have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies. • The proposed Voluson Expert Series 22/20/18 and predicate systems have be en designed in compliance with ap proved electrical and physical safety standards. • There proposed Voluson Expert Series 22/20/18 and predicate Voluson E10 system Software Features are equivalent. Some minor improvements to the existing Software features have been implemented into the proposed system. • The proposed Voluson Expert Series 22/20/18 adds additional AI software features SonoPelvicFloor and SonoLyst/ Sonolyst Live (workflow improvement) to the system. 5 • The proposed Voluson Expert Series 22/20/18 adds additional software features Shadow Reduction , Adapt and Sono FHR (Performance improvement) to the system. • The proposed Voluson Expert Series 22/20/18 migrated from (K192159) the following software features Elastography, Shear Wave Elastography , CW Doppler Mode and Acquisition mode Contrast.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsmeasurement or quantification
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 2,748 reports filed against devices carrying product code IYN. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · ACUSON Origin Ultrasound System · Siemens Medical Solutions USA, Inc. · report 3023245-2026-00096
30 September 2026 · Malfunction · ACUSON Sequoia Ultrasound System · Siemens Medical Solutions USA, Inc. · report 3023245-2026-00097
30 September 2026 · Malfunction · AFFINITI 30 · Philips Ultrasound, Inc · report 3019216-2026-100325
30 September 2026 · Injury · EPIQ 5G · Philips Ultrasound, Inc · report 3019216-2026-100326
29 September 2026 · Malfunction · ACUSON Juniper · Siemens Medical Solutions USA, Inc. · report 3023245-2026-00091
One of the patient exams performed on the Juniper system displays an "Unarchived" error message and they are unable to send this study to PACS. All other exams performed before are after this one are transferring over to the PACS as expected without any errors. The problem occurred after a Breast study was completed and the user tried to send it over to the network PACS. TSE worked with the customer and she confirmed that the problem cannot be reproduced, as it only is affecting this one exam. […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code IYN, in Radiology, from GE Medical Systems Ultrasound and Primary Care Diagnostics,, or cleared in 2022. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.