Radiology · 510(k) · 2023
uOmnispace.MI
Shanghai United Imaging Healthcare Co., Ltd.. Cleared by FDA on 20 December 2023 under submission K233176, product code LLZ (system, image processing, radiological). What FDA's record says, in FDA's words.
Device record · K233176
- Device. uOmnispace.MIDEVICE
- Company. Shanghai United Imaging Healthcare Co., Ltd. (CN)COMPANY
- Decision. 20 December 2023, 510(k), substantially equivalent (traditional review); received 28 September 2023DECISION
- Panel. RadiologyPANEL
- Product code. LLZ, System, Image Processing, RadiologicalCODE
- Regulation. 21 CFR 892.2050, Class IIREG
- Source. FDA database entry · decision document (18 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.
uOmnispace.MI is a software solution intended to be used for viewing, processing, evaluating and analyzing of PET, CT, MR, SPECT images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications: uOmnispace.MI MM Fusion is intended to provide tools for viewing, analyzing and reporting PET, CT, MR, SPECT data with its flexible workflow and optimized layout protocols for dedicated reporting purposes on oncology, neurology, and cardiology. uOmnispace.MI MM Oncology application is intended to provide tools to display and analyze the follow -up PET, CT, and MR data, with which users can do image registration, lesion segmentation, and statistical analysis. uOmnispace.MI Dynamic Analysis application is intended to display PET data and anatomical data such as CT or MR, and supports to do lesion segmentation and output associated time activity curve. uOmnispace.MI NeuroQ application is intended to analyze the brain PET scan, give quantitative results of the relative activity of different brain regions, and make
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
- Mentionsmeasurement or quantification
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 Shanghai United Imaging Healthcare Co., Ltd., or cleared in 2023. The whole record is at FDA AI-enabled medical devices.
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