Radiology · 510(k) · 2017
BladderScan Prime PLUS System
Verathon Incorporated. Cleared by FDA on 15 September 2017 under submission K172356, product code IYO (system, imaging, pulsed echo, ultrasonic). What FDA's record says, in FDA's words.
Device record · K172356
- Device. BladderScan Prime PLUS SystemDEVICE
- Company. Verathon IncorporatedCOMPANY
- Decision. 15 September 2017, 510(k), substantially equivalent (traditional review); received 3 August 2017DECISION
- Panel. RadiologyPANEL
- Product code. IYO, System, Imaging, Pulsed Echo, UltrasonicCODE
- Regulation. 21 CFR 892.1560, 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.
, have biosafety equivalence and are manufactured using ISO 13485 quality management system. Verathon Inc. believes that the BladderScan PRIME PLUS system is substantially equivalent with regard to safety and effectiveness to the legally marketed predicate device. Verathon048
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.
- Mentionsnone of the tracked terms matched
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 6,627 reports filed against devices carrying product code IYO. 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 · MEDLINE · Medline Industries, LP · report 1417592-2026-53998
It was reported that PRODUCT SCREEN COMES UP WITH ERROR CODE E005 BATTERY ERROR.
30 September 2026 · Injury · ViewFlex¿ICE Catheter · Abbott Medical · report 2030404-2026-00047
The following was published in the JACC: CASE REPORTS, "AIatrogenic VSD, Closure Attempt With Complications, and Ultimate Success", Jakob Schroder, MD, PHD, Niels Vejlstrup, MD, PHD, Laurence Campens, MD, PHD, Michael Rahbek Schmidt, MD, PHD, DMSC. VOL. 31, NO. 7, 202 6BACKGROUND Iatrogenic postsurgical ventricular septal defect (VSD) is a rare complication of surgical aortic valve replacement (SAVR). CASE SUMMARY A patient presented with left-sided heart failure due to an initially missed […]
30 September 2026 · Malfunction · MEDLINE CO-LABEL · Medline Industries, LP · report 1417592-2026-54811
30 September 2026 · Malfunction · MEDLINE CO-LABEL · Medline Industries, LP · report 1417592-2026-55041
30 September 2026 · Malfunction · Site~Rite 8 Scanner · C.R. Bard, Inc. (BASD) -3006260740 · report 3006260740-2026-07105
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 IYO, in Radiology, or cleared in 2017. 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.