510(k) · Cleared
ClearedQuickRad
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aikenist Technologies Pvt, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Feb 21, 2025 as substantially equivalent to K222781 (Deeptek Medical Imaging Private Limited, 2023) after a 155-day review. Its family tree reaches back 8 generations to 1994.
- Decided
- Feb 21, 2025
- Review
- 155 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K942120 (1994). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 7 generations backK013630 Isite RadiologyStentor, Inc. · 2001
- 6 generations backK031311 Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003
- 5 generations backK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
- 4 generations backK052545 Infinitt G3 PacsInfinitt Co., Ltd. · 2005
- 3 generations backK163290 INFINITT ULiteInfinitt Co., Ltd. · 2017
- 2 generations backK211480 NubeXTechheim Co., Ltd. · 2021
- 1 generation backK222781 AugmentoDeeptek Medical Imaging Private Limited · 2023
- This deviceK242838 QuickRadAikenist Technologies Pvt, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K942120 | Advantage Windows Diagnostic X-Ray Workstation | GE Medical Systems | 1994 | — |
| −7 | K013630 | Isite Radiology | Stentor, Inc. | 2001 | — |
| −6 | K031311 | Integradweb by Dynamic Imaging, Inc. | Dynamic Imaging, Inc. | 2003 | — |
| −5 | K042313 | Integradweb MPR/Mip | Dynamic Imaging, Inc. | 2004 | — |
| −4 | K052545 | Infinitt G3 Pacs | Infinitt Co., Ltd. | 2005 | — |
| −3 | K163290 | INFINITT ULite | Infinitt Co., Ltd. | 2017 | — |
| −2 | K211480 | NubeX | Techheim Co., Ltd. | 2021 | — |
| −1 | K222781 | Augmento | Deeptek Medical Imaging Private Limited | 2023 | — |
| 0 (this device) | K242838 | QuickRad | Aikenist Technologies Pvt, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K222781 | AugmentoSummary page 5…Augmento Device Manufacturer Name DEEPTEK MEDICAL IMAGING PRIVATE LIMITED 510(k) Number K222781 Regulation Number 21 CFR 892.2050 Device Class Class 2… | 2023 |
| † | K231149 | qXR-CTR | 2023 |
| † | K212624 | EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System | 2022 |
| † | K233226 | FlexView Diagnostic (v1.1.20) | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- None of the 11 ancestors has a recall.
- 1 other device also cites its predicate K222781.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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. The system enhances communication and accessibility by allowing distributed access to images and data across computer networks. QuickRad also…
Read the full statement (137 words)
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. The system enhances communication and accessibility by allowing distributed access to images and data across computer networks. QuickRad also offers optional integration with FDA-cleared third-party Al models, enabling the visualization of Al-generated outputs. The system displays these outputs "as-is," with the safety and effectiveness of the Al models being covered under the original third-party manufacturer's regulatory clearance. Mammographic images may only be interpreted using a monitor that meets the technical specifications identified by the FDA. The system is designed for utilization by proficient and certified medical practitioners, including physicians, radiologists, and medical technicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242838 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242838: QuickRad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242838
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026