Radiology · 510(k) · 2017
SmartTarget
SmartTarget, Ltd.. Cleared by FDA on 7 June 2017 under submission K170250, product code LLZ (system, image processing, radiological). What FDA's record says, in FDA's words.
Device record · K170250
- Device. SmartTargetDEVICE
- Company. SmartTarget, Ltd. (GB)COMPANY
- Decision. 7 June 2017, 510(k), substantially equivalent (traditional review); received 27 January 2017DECISION
- Panel. RadiologyPANEL
- Product code. LLZ, System, Image Processing, RadiologicalCODE
- 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.
N 1XPEHU(if known) )RUP$SSURYHG 20%1R ([SLUDWLRQ'DWH -DQXDU\ See PRA Statement below. 'HYLFH1DPH SmartTarget ,QGLFDWLRQVIRU8VH(Describe) The SmartTarget device is intended as an accessory for image-guided interventional and diagnostic procedures involving the prostate gland, and to be used by physicians for enhanced visualization of two-dimensional (2D) transrectal ultrasound TRUS images of the prostate in clinic and hospital settings. It allows the user to segment medical images and it performs three-dimensional (3D) reconstruction of digitized TRUS video images to form a 3D TRUS volume. The SmartTarget software provides 2D and 3D image visualization features, including the ability to review images, generate multi-planar views, annotate images, and identify and record the locations of instruments inserted during the procedure. The device is intended to be used in diagnostic and treatment procedures in a clinical setting in which a needle or other instrument is inserted into the prostate through the perineum or urethra, or instruments that are positioned externally to the prostate so that treatment can be delivered to prostate tissue, or diagnostic information obtained from prostate tissue. Example procedures include, but are not limited to: needle biopsy in which tissue samples are removed from the prostate; in situ diagnostic techniques, such as those based on optical sensing; thermal tissue ablation using radiofrequency, […]
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
- Mentionsdetection or identification of findings
- 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, 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.