Radiology · 510(k) · 2019
Merge PACS
Merge Healthcare Incorporated. Cleared by FDA on 17 October 2019 under submission K192455, product code LLZ (system, image processing, radiological). What FDA's record says, in FDA's words.
Device record · K192455
- Device. Merge PACSDEVICE
- Company. Merge Healthcare IncorporatedCOMPANY
- Decision. 17 October 2019, 510(k), substantially equivalent (traditional review); received 9 September 2019DECISION
- Panel. RadiologyPANEL
- Product code. LLZ, System, Image Processing, RadiologicalCODE
- Regulation. 21 CFR 892.2050, Class IIREG
- Source. FDA database entry · decision document (19 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.
Merge PACS is a Picture Archiving and Communication System (PACS) for multi-modality (CT, MR, PT, US, MG, BTO, CR, DR/DX, NM, XA, RF, secondary capture (SC), and other DICOM-compliant modalities) image processing and display, diagnostic reading and reporting, communication, printing, and storage of medical imaging studies and other patient data. Intended clinical users include radiologists, orthopedic and other surgeons, referring physicians, technologists, and other qualified medical professionals. Data can be received directly from acquisition modalities, CAD systems, and other image processing systems, or indirectly via importing. Data that is not DICOM-compliant, such as photos, can be converted to DICOM format by Merge PACS. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR, and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae). The Real Time Worklist (RTWL) displays the real-time status of radiology activity and provides customizable workflow management capabilities. Communication of critical results is facilitated and documented through optional, configurable components. The Patient Dashboard provides a composite view of patient data, both imaging and non-imaging. Multi-tier patient identity matching provides a […]
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
- Mentionstriage or notification
- 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 2019. 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.