Radiology · 510(k) · 2024
SpineUs System
Verdure Imaging. Cleared by FDA on 7 October 2024 under submission K241029, product code IYO (system, imaging, pulsed echo, ultrasonic). What FDA's record says, in FDA's words.
Device record · K241029
- Device. SpineUs SystemDEVICE
- Company. Verdure ImagingCOMPANY
- Decision. 7 October 2024, 510(k), substantially equivalent (traditional review); received 15 April 2024DECISION
- Panel. RadiologyPANEL
- Product code. IYO, System, Imaging, Pulsed Echo, UltrasonicCODE
- Regulation. 21 CFR 892.1560, Class IIREG
- Source. FDA database entry · decision document (13 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 SpineUs system is a software-based, tracked, ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging in the following applications: musculoskeletal (conventional, superficial). The system is intended for use by trained chiropractors and radiologists in a hospital or medical clinic. The Spine Us TM system is intended for assisting trained chiropractors and radiologists in acquiring, viewing, and measuring ultrasound images of the spine in both clinic and hospital settings. The SpineUs TM system is intended to be used as an adjunct to conventional imaging method that allows trained chiropractors and radiologists to measure spine-related anatomical components on images (e.g., intervertebral angles and spine curvature). The system also allows the review and management of patient measurement data. Clinical judgment of anatomy and experience are required to properly use the Spine Us TM system. Patient management decisions should not be made based solely on the results of the SpineUs TM computer application. The user shall retain the ultimate responsibility of ascertaining the measurements based on standard practices and clinical judgement.
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.
- Modalities namedultrasound
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
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 2024. 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.