510(k) · Cleared
ClearedRadlink GPS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radlink, Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Dec 17, 2014 as substantially equivalent to K141440 (Oehm Und Rehbein GmbH, 2014) and 2 other predicates after an 85-day review. Its family tree reaches back 8 generations to 1981. 1 later device descends from it.
- Decided
- Dec 17, 2014
- Review
- 85 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K803130 (1981). 34 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 7 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 6 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 5 generations backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- 4 generations backK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- 3 generations backK083645 Radstar Family, Models: Radstar 4343 & Variations5 Star Medical, Inc. · 2009
- 2 generations backK131211 Dicompacs DX-R with Flat PanelOehm Und Rehbein GmbH · 2013
- 1 generation backK141440 Dicompacs DX-R with Flat PanelOehm Und Rehbein GmbH · 2014
- This deviceK142718 Radlink GPSRadlink, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK242161 Radlink GPS Pro ImagingRadlink, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K242161Radlink GPS Pro ImagingRadlink, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −7 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −6 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −5 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| −4 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| −3 | K083645 | Radstar Family, Models: Radstar 4343 & Variations | 5 Star Medical, Inc. | 2009 | — |
| −2 | K131211 | Dicompacs DX-R with Flat Panel | Oehm Und Rehbein GmbH | 2013 | — |
| −1 | K141440 | Dicompacs DX-R with Flat Panel | Oehm Und Rehbein GmbH | 2014 | — |
| 0 (this device) | K142718 | Radlink GPS | Radlink, Inc. | 2014 | — |
| +1 | K242161 | Radlink GPS Pro Imaging | Radlink, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 MQB? 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 MQB device
- #1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K141440 | Dicompacs DX-R with Flat PanelSummary page 5…GPS COMMON NAME: Digital X-Ray Receptor Panel CLASSIFICATION NAME: Stationary X-ray system (Class 2 Device) PRODUCT CODE: MQB. Regulation 892.1680 (3) PREDICATE DEVICE: K141440, dicomPACS DX-R, O&R (4) DEVICE DESCRIPTION The Radlink GPS system represents the straightforward integration of digital x-ray r… | 2014 |
| * | K052938 | CR-PROSummary page 5…ls with their own FDA 510(k) clearance and our acquisition software that has been previously cleared by the FDA for use with our Radlink CR-Pro Solid State X-ray Imager (K052938) and Radlink LaserPro-16 (K020243). The Radlink GPS is compatible with the following digital x-ray receptor panels: - Viework… | 2005 |
| * | K020243 | Laserpro 16Summary page 5…ance and our acquisition software that has been previously cleared by the FDA for use with our Radlink CR-Pro Solid State X-ray Imager (K052938) and Radlink LaserPro-16 (K020243). The Radlink GPS is compatible with the following digital x-ray receptor panels: - Vieworks VIVIX-S (K120020) and VIVIX-S Wi… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242161 | Radlink GPS Pro Imaging | 2025 | 0 |
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 33 years and passes through 7 companies; a new generation was cleared every 3.3 years on median.
- 10 of the 34 ancestors have a recall of any class.
- Of its descendants, K242161 (Radlink, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MQB devicesMQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MQB
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQB
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQB
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQB
141in 2025
MAUDE reports naming product code MQB, 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 | 13 | 22 | 15 | 25 |
| 2008 | 8 | 15 | 36 | 30 |
| 2009 | 15 | 57 | 19 | 34 |
| 2010 | 11 | 116 | 14 | 39 |
| 2011 | 24 | 102 | 10 | 101 |
| 2012 | 22 | 80 | 8 | 267 |
| 2013 | 21 | 105 | 6 | 159 |
| 2014 | 32 | 102 | 0 | 29 |
| 2015 | 21 | 81 | 0 | 21 |
| 2016 | 22 | 92 | 0 | 26 |
| 2017 | 31 | 30 | 1 | 20 |
| 2018 | 16 | 30 | 4 | 84 |
| 2019 | 22 | 30 | 1 | 45 |
| 2020 | 19 | 28 | 4 | 9 |
| 2021 | 21 | 48 | 1 | 26 |
| 2022 | 31 | 48 | 0 | 13 |
| 2023 | 10 | 30 | 0 | 51 |
| 2024 | 8 | 187 | 0 | 91 |
| 2025 | 8 | 127 | 1 | 141 |
| 2026 | 3 | 245 | 1 | — |
What is it indicated for?
Radlink GPS is intended for digital image capture use in general radiographic examinations, whenever conventional screen-film systems may be used. Radlink GPS allows imaging of the pelvis, knee, skull, chest, shoulder, spine, abdomen and extremities. The digital images are transmitted from the panel or from a connection to PACS via computer networks or from a video input port to a personal computer (PC) where they may be displayed, processed, altered, overlaid with templates, compressed for archiving or transmission via computer networks to other medical facility sites. Not for mammography.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142718 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142718: Radlink GPS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142718
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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