Radiology · 510(k) · 2025
BioTraceIO Vision (V1.7)
Techsomed Medical Technologies. Cleared by FDA on 8 September 2025 under submission K251931, product code QTZ (radiological image processing software for ablation therapy planning and evaluation). What FDA's record says, in FDA's words.
Device record · K251931
- Device. BioTraceIO Vision (V1.7)DEVICE
- Company. Techsomed Medical Technologies (IL)COMPANY
- Decision. 8 September 2025, 510(k), substantially equivalent (traditional review); received 24 June 2025DECISION
- 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 (14 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.
if it is known. This K251931Please type in the marketing application/submission number, textbox will be left blank for original applications/submissions. Please provide the device trade name(s). ? IBioTracelO Vision (V1.7) Please provide your Indications for Use below. BioTracelO Vision is a Computed Tomography (CT) and Magnetic Resonance (MR) image processing software package available for use with ablation procedures. BioTracelO Vision is controlled by the user via a user interface. BioTracelO Vision imports images from CT and MR scanners and facility PACS systems for display and processing during ablation procedures. BioTracelO Vision is used to assist physicians in planning ablation procedures, including identifying ablation targets and virtual ablation needle placement. BioTracelO Vision 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. I Z Prescription Use (Part 21 CFR 801 Subpart D) D Over-The-Counter Use (21 CFR 801 Subpart C) Please select the types of uses (select one or both, as applicable). BioTracelO Vision 510(K) SUMMARY Techsomed’s BioTraceIO Vision Submitter Techsomed Medical Technologies LTD. 6 Ofra Haza St. Or Yehuda 6032303 ISRAEL Phone: +972545595951 Contact Person: Dalia Dickman, PhD. Date Prepared: September 4, 2025 Name of Device: BioTraceIO Vision (V1.7) Common or Usual Name: BioTraceIO Vision
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
- Mentionsprescription use
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, or cleared in 2025. 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.