Radiology · 510(k) · 2020
Quantib Prostate
Quantib BV. Cleared by FDA on 11 October 2020 under submission K202501, product code LLZ (system, image processing, radiological). What FDA's record says, in FDA's words.
Device record · K202501
- Device. Quantib ProstateDEVICE
- Company. Quantib BV (NL)COMPANY
- Decision. 11 October 2020, 510(k), substantially equivalent (traditional review); received 31 August 2020DECISION
- Panel. RadiologyPANEL
- Product code. LLZ, System, Image Processing, RadiologicalCODE
- Regulation. 21 CFR 892.2050, Class IIREG
- Source. FDA database entry · decision document (10 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.
Quantib Prostate is image post-processing software that provides the user with processing, visualization, and editing of prostate MRI images. The software facilitates the analysis and study review of MR data sets and provides additional mathematical and/or statistical analysis. The resulting analysis can be displayed in a variety of formats, including images overlaid onto source MRI images. Quantib Prostate functionality includes registered multiparametric-MRI viewing, with the option to view images combined into a single image to support visualization. The software can be used for semi-automatic segmentation of anatomical structures and provides volume computations, together with tools for manual editing. PI-RADS scoring is possible using a structured workflow. Quantib Prostate is intended to be used by trained medical professionals and provides information that, in a clinical setting, may assist in the interpretation of prostate MR studies. Diagnosis should not be made solely based on the analysis performed using Quantib Prostate.
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 namedMRI
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 19,970 reports filed against devices carrying product code LLZ. 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 · IntelliSpace Cardiovascular · Philips Medical Systems Nederland B.V. · report 3003768277-2026-101631
Philips received a complaint on the IntelliSpace Cardiovascular (ISCV) indicating that the ISCV could only be accessed in Web-Only mode on the workstation. The device was in clinical use at the time of the event, and no adverse events or harm were reported in the complaint ((b)(4)).Philips has started an investigation of this complaint.
30 September 2026 · Malfunction · IntelliSpace Cardiovascular · Philips Medical Systems Nederland B.V. · report 3003768277-2026-101632
Philips received a complaint on the IntelliSearch Cardiovascular (ISCV) indicating that customer reported that study retrieval from the archive was either failing or taking an excessively long time to complete. The device was in clinical use at the time of the event, and no adverse events or harm were reported in the complaint (b)(4).Philips has started an investigation of this complaint.
30 September 2026 · Malfunction · IntelliSpace CardioVascular · Philips Medical Systems Nederland B.V. · report 3003768277-2026-101634
Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein the user was reported that DICOM import crashed occasionally as there was a PDFClinicalContentExecuter error.. The device was in clinical use at the time of event.Based on the new information that Philips became aware, this has been determined to be a reportable malfunction. Under specific circumstances, it could potentially lead to delayed diagnosis. Given the defect¿s nature and its potential impact on […]
30 September 2026 · Malfunction · IntelliSpace CardioVascular · Philips Medical Systems Nederland B.V. · report 3003768277-2026-101635
Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein the user could not save the findings. The device was in clinical use at the time of event. Based on the new information that Philips became aware, this has been determined to be a reportable malfunction. Under specific circumstances, it could potentially lead to delayed diagnosis. Given the defect¿s nature and its potential impact on clinical decision-making if it were to recur, it is determined that this […]
30 September 2026 · Malfunction · IntelliSpace Cardiovascular · Philips Medical Systems Nederland B.V. · report 3003768277-2026-101636
Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein user reported that it was not possible to view previous studies in Echo Module. The device was in clinical use at the time of event. Based on the new information that Philips became aware, this has been determined to be a reportable malfunction. Under specific circumstances, it could potentially lead to delayed diagnosis. Given the defect¿s nature and its potential impact on clinical decision-making if it […]
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 LLZ, in Radiology, from Quantib BV, or cleared in 2020. 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.