510(k) · Cleared
ClearedRadlink GPS Pro Imaging
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radlink, Inc. · LLZ System, Image Processing, Radiological
Cleared on Mar 18, 2025 as substantially equivalent to K231503 (DePuy Orthopaedics, Inc., 2023) and 1 other predicate after a 237-day review. Its family tree reaches back 12 generations to 1990.
- Decided
- Mar 18, 2025
- Review
- 237 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K896095 (1990). 62 ancestors in all, the oldest K803130 (1981). No later device cites it as a predicate yet.
- Root · 12 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 8 generations between
- 3 generations backK160284 JointPointJointpoint, Inc. · 2016
- 2 generations backK203651 CuptimizeCuptimize, Inc. · 2021
- 1 generation backK231503 CUPTIMIZE™ AdvancedDePuy Orthopaedics, Inc. · 2023
- This deviceK242161 Radlink GPS Pro ImagingRadlink, Inc. · 2025
Show all 12 generations
- Root · 12 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 11 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 10 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 9 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 8 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 7 generations backK032401 OrthoviewOmsbar, Ltd. · 2003
- 6 generations backK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- 5 generations backK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- 4 generations backK142923 TraumaCad Mobile Release 1.0Voyant Health, Ltd. · 2015
- 3 generations backK160284 JointPointJointpoint, Inc. · 2016
- 2 generations backK203651 CuptimizeCuptimize, Inc. · 2021
- 1 generation backK231503 CUPTIMIZE™ AdvancedDePuy Orthopaedics, Inc. · 2023
- This deviceK242161 Radlink GPS Pro ImagingRadlink, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −11 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −10 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −9 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −8 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −7 | K032401 | Orthoview | Omsbar, Ltd. | 2003 | — |
| −6 | K042816 | Traumacad 1.2 | Orthocrat, Ltd. | 2004 | — |
| −5 | K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | 2008 | — |
| −4 | K142923 | TraumaCad Mobile Release 1.0 | Voyant Health, Ltd. | 2015 | — |
| −3 | K160284 | JointPoint | Jointpoint, Inc. | 2016 | — |
| −2 | K203651 | Cuptimize | Cuptimize, Inc. | 2021 | — |
| −1 | K231503 | CUPTIMIZE™ Advanced | DePuy Orthopaedics, Inc. | 2023 | — |
| 0 (this device) | K242161 | Radlink GPS Pro Imaging | Radlink, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K231503 | CUPTIMIZE™ AdvancedSummary page 5…er: 892.2050 • Device Class: II • Product Code: LLZ Predicate & Reference Devices: • Primary Predicate Device: CUPTIMIZE™ Advanced (K231503), Regulation Number: 892.2050, Product Code: LLZ • Secondary Predicate Device: Radlink® GPS (K142718), Regulatio… | 2023 |
| * | K142718 | Radlink GPSSummary page 5…Primary Predicate Device: CUPTIMIZE™ Advanced (K231503), Regulation Number: 892.2050, Product Code: LLZ • Secondary Predicate Device: Radlink® GPS (K142718), Regulation Number: 892.1680, Product Code: LLZ/MQB • Reference Device: K233761 Indications for Use: Radlink GP… | 2014 |
| † | K233761 | Orthopaedic Surgery Planning Software (AIJOINT) | 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 35 years and passes through 10 companies; a new generation was cleared every 2.5 years on median.
- 15 of the 62 ancestors have a recall of any class.
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?
Radlink GPS Pro Imaging is an image-processing software intended to assist in hip procedures by measuring the acetabulum’s position relative to local bone structures identified from radiological images. The device allows for overlaying digital annotations on radiological images and includes tools for performing measurements using the images and digital annotations. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242161 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242161: Radlink GPS Pro Imaging.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242161
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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