Radiology · 510(k) · 2024
VisAble.IO
Techsomed. Cleared by FDA on 15 April 2024 under submission K240773, product code QTZ (radiological image processing software for ablation therapy planning and evaluation). What FDA's record says, in FDA's words.
Device record · K240773
- Device. VisAble.IODEVICE
- Company. Techsomed (IL)COMPANY
- Decision. 15 April 2024, 510(k), substantially equivalent (special review); received 21 March 2024DECISION
- Panel. RadiologyPANEL
- Product code. QTZ, Radiological Image Processing Software For Ablation Therapy Planning And EvaluationCODE
- Regulation. 21 CFR 892.2050, 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.
VisAble.IO is a Computed Tomography (CT) and Magnetic Resonance (MR) image processing software package available for use with liver ablation procedures. VisAble.IO is controlled by the user via a user interface. VisAble.IO imports images from CT and MR scanners and facility PACS systems for display and processing during liver ablation procedures. VisAble.IO is used to assist physicians in planning ablation procedures, including identifying ablation targets and virtual ablation needle placement. VisAble.IO is used to assist physicians in confirming ablation zones. The software is not intended for diagnosis. The software is not intended to predict ablation volumes or predict ablation success.
The product code's definition, from FDA's classification record. To provide radiological image processing tools for planning, monitoring, and evaluating ablation therapy.
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 namedCT, MRI
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QTZ. 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.
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 QTZ, in Radiology, from Techsomed, 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.