QuickRad
K242838Aikenist Technologies Pvt Ltd · cleared 2025-02-21 · product code LLZ · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“QuickRad is a web-based PACS intended for use in radiology centers, diagnostic labs, and hospitals. It is designed to receive, store, transmit, process, and display medical images and associated data from various DICOM-compliant sources, including CT scanners, MRI systems, ultrasound machines, and X-ray devices.”
source quote (p.4)
“QuickRad also offers optional integration with FDA-cleared third-party AI models, enabling the visualization of AI-generated outputs.”
source quote (p.10)
“QuickRad underwent a thorough hazard analysis, addressing both intentional and unintentional risks in compliance with ISO 14971:2019. Strategies to mitigate these risks were implemented to ensure safety throughout the device lifecycle, and the hazard analysis and mitigation strategies were validated, confirming QuickRad's compliance with ISO 14971:2019. Periodic VAPT by third-party consultants were conducted to verify the adequacy of QuickRad's security controls, effectively mitigating potential cybersecurity risks.”
Validation studies (2)
Bench
n=12 images
endpoints: demonstrated that QuickRad's angle measurement tool is substantially equivalent to FlexView Diagnostic and produced clinically reliable angle assessments
standards: ISO 14971:2019, IEC 62366-1:2015, ISO 13485: 2016 Edition 3, IEC 62304 Edition 1.1 2015-06 Consolidated Version, NEMA PS 3.1 - 3.20 2023e, IEC ISO 10918-1 First edition 1994-02-15
Bench
sample size not stated
endpoints: confirmed that QuickRad delivers performance equivalent to the FDA-cleared FlexView Diagnostic DICOM Viewer (K233226), ensuring consistent, reliable, and clinically accurate measurements across the spectrum of diagnostic imaging
standards: ISO 14971:2019, IEC 62366-1:2015, ISO 13485: 2016 Edition 3, IEC 62304 Edition 1.1 2015-06 Consolidated Version, NEMA PS 3.1 - 3.20 2023e, IEC ISO 10918-1 First edition 1994-02-15
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
- 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
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (DICOM Grid, Inc., initiated 2025-11-18): "Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97993
- …and 20 more.
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). 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).