Radiology · 510(k) · 2025
Clarify DL
GE Medical Systems Israel, Functional Imaging. Cleared by FDA on 3 January 2025 under submission K241350, product code LLZ (system, image processing, radiological). What FDA's record says, in FDA's words.
Device record · K241350
- Device. Clarify DLDEVICE
- Company. GE Medical Systems Israel, Functional Imaging (IL)COMPANY
- Decision. 3 January 2025, 510(k), substantially equivalent (traditional review); received 13 May 2024DECISION
- Panel. RadiologyPANEL
- Product code. LLZ, System, Image Processing, RadiologicalCODE
- Regulation. 21 CFR 892.2050, Class IIREG
- Source. FDA database entry · decision document (8 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.
Clarify DL is a deep learning-based image reconstruction method intended to reduce noise and improve image quality of Nuclear Medicine bone SPECT scintigraphy images. Clarify DL may be used for patients of all ages. Technology Characteristics Clarify DL is an additional image reconstruction option for the predicate Xeleris V Processing and Review System and StarGuide devices . Clarify DL produces substantially equivalent images to those produced using the predicate devices’ cleared image reconstruction. Because Clarify DL is deployed within the predicate Xeleris V and StarGuide devices software, it utilizes the same hardware and software platform as their cleared image reconstruction. The tables below summarize the substantive feature / technological differences between the predicate device and the proposed device: Specification Predicate Device 1 Xeleris V Processing and Review System (K221680) Proposed Device Clarify DL on Xeleris V Technology OSEM-based Iterative Image Reconstruction OSEM-based Iterative Image Reconstruction with integrated deep learning model trained to reduce noise GE Healthcare 510(k) Premarket Notification Submission for Clarify DL 3 Specification Predicate Device 2 StarGuide (K221680) including Smart Console Proposed Device Clarify DL on StarGuide’s Smart Console Technology OSEM-based and BSREM-based Iterative Image Reconstruction OSEM-based and BSREM-based Iterative Image Reconstruction with integrated deep learning model trained to reduce noise […]
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.
- Mentionstriage or notification
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 GE Medical Systems Israel, Functional Imaging, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
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