Radiology · 510(k) · 2022
Venue
GE Medical Systems. Cleared by FDA on 27 June 2022 under submission K220851, product code IYN (system, imaging, pulsed doppler, ultrasonic). What FDA's record says, in FDA's words.
Device record · K220851
- Device. VenueDEVICE
- Company. GE Medical SystemsCOMPANY
- Decision. 27 June 2022, 510(k), substantially equivalent (traditional review); received 23 March 2022DECISION
- Panel. RadiologyPANEL
- Product code. IYN, System, Imaging, Pulsed Doppler, UltrasonicCODE
- Regulation. 21 CFR 892.1550, Class IIREG
- Source. FDA database entry · decision document (12 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 proposed Venue and predicate Venue (K202132) have identical imaging modes. The following is an overview of the differences between the GE Healthcare 510(k) Premarket Notification Submission Page 5 o f 9 proposed Venue and the predicate Venue: The proposed Venue and predicate Venue (K202132) systems transducers are similar, except for: Additions of M5Sc-RS which was first cleared on Vivid iq K161706. This probe is used unchanged from the cleared reference device (K161706). It is made of the same materials and its shape is unchanged. The clinical indications of M5Sc-RS are the same on the proposed Venue as they are on the reference device Vivid E95 K202658 with M5Sc-D probe. The M5Sc-RS probe is the same as the M5Sc-D except it uses an RS connector instead of a D connector. The transducer body is identical between the two. New applications are added to the following transducers: o M5Sc-RS transducer: added Ophthalmic application. This application was already cleared with 3Sc-RS in predicate Venue (K202132) which is a similar transducer. o 3Sc-RS, E8C-RS, 6S-RS, 12S-RS: added Nonvascular access to the Interventional guidance application which was already cleared with these probes on reference device Versana Premier (K210438). Features/Functionality: Scribble: assists the user during system training and teach ing by providing a touch-operated pointer and free drawing capabilities. Power Doppler Imaging+ (PDI+): is intended for slow blood flows like those found in […]
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.
- Mentionstriage or notification
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, 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.