Merge PACS

K192455

Merge Healthcare Incorporated · cleared 2019-10-17 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.7)
“Merge PACS, a software medical device, is a standards-based medical imaging diagnostic workstation that serves as an adjunct to assist the clinician to view, read, and report their findings. The software documentation was provided at a Moderate level of concern following the FDA's “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".”
AlgorithmRegion Analysis Area and Region Analysis Volume tools for 2D and 3D SUV calculations; Automatic Registration for series that do not share a common frame of reference.
source quote (p.7)
“The focus of this premarket notification is on the addition of the Region Analysis Area and Region Analysis Volume tools, which allows for additional clinical analysis of images, including volumetric Standard Uptake Value (SUV) calculation. Addition of Region Area and Volume Analysis tools allows for additional clinical analysis of PET images for patient treatment, including 3D SUV calculations. Automatic registration is through the functionality of Blackford to deliver DICOM objects to Merge PACS for automatic registration of series that do not share a common frame of reference.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.18)
“Cybersecurity is also addressed in this submission.”

Validation studies (1)

Bench

sample size not stated

endpoints: Risk Analysis; Requirements Review; Design Reviews; Testing on unit level; Integration testing; Performance testing

standards: DICOM – Digital Imaging and Communications in Medicine, for the format of medical images and data, NEMA PS 3.1 – 3.20 Set (2016)

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

48
recalls in product code, 24mo
295
MAUDE reports in code, 12mo
+683%
vs code's own 3-yr baseline
26
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Merge Healthcare, Inc., initiated 2025-02-19): "When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clini" Recalling firm matches this device's applicant.

    first seen 2026-07-08 · recall res_event_number:96344

  • adverse_event_inflection

    MAUDE adverse-event reports for product code LLZ: 295 in the 12 months ending 2026-06, vs a 37.7/12mo average over the prior 3 windows (+683%). Code-level count — reports are not attributed to this specific device.

    first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=LLZ

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (GE Medical Systems SCS, initiated 2026-05-08): "GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:99042

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2026-03-05): "Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98520

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (GE Medical Systems, LLC, initiated 2026-01-30): "There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98428

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Focalyx Technologies, LLC., initiated 2025-12-23): "Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, wh" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98137

  • …and 20 more.

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Merge Healthcare, Inc.) — same firm and product code, not necessarily this device · initiated 2025-02-19

    When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.

    recall event 96344 (openFDA)

  • Recalling firm matches this device's applicant (Merge Healthcare, Inc.) — same firm and product code, not necessarily this device · initiated 2025-02-19

    When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.

    recall event 96344 (openFDA)

  • Recalling firm matches this device's applicant (Merge Healthcare, Inc.) — same firm and product code, not necessarily this device · initiated 2025-02-19

    When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.

    recall event 96344 (openFDA)

  • Recalling firm matches this device's applicant (Merge Healthcare, Inc.) — same firm and product code, not necessarily this device · initiated 2025-02-19

    When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.

    recall event 96344 (openFDA)

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K192455