510(k) · Cleared
ClearedRadstar Family, Models: Radstar 4343 & Variations
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
5 Star Medical, Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Feb 24, 2009 as substantially equivalent to K081648 (Canon, Inc., 2008) and 1 other predicate after a 77-day review. Its family tree reaches back 5 generations to 1981. 6 later devices descend from it.
- Decided
- Feb 24, 2009
- Review
- 77 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K803130 (1981). 22 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 4 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 3 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 2 generations backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- 1 generation backK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- This deviceK083645 Radstar Family, Models: Radstar 4343 & Variations5 Star Medical, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK131211 Dicompacs DX-R with Flat PanelOehm Und Rehbein GmbH · 2013
- Descendant · 2 generations on · 2 of its ownK141440 Dicompacs DX-R with Flat PanelOehm Und Rehbein GmbH · 2014
- Descendant · 3 generations on · 1 of its ownK142718 Radlink GPSRadlink, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK101435 Imix Panorad and SomaradImix Adr Finland OY · 2010
- Descendant · 4 generations on · 0 of its ownK242161 Radlink GPS Pro ImagingRadlink, Inc. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K131211Dicompacs DX-R with Flat PanelOehm Und Rehbein GmbH · 2013 · cites it directly3descendants
- K141440Dicompacs DX-R with Flat PanelOehm Und Rehbein GmbH · 2014 · 2 generations on2descendants
- K142718Radlink GPSRadlink, Inc. · 2014 · 3 generations on1descendant
- K101435Imix Panorad and SomaradImix Adr Finland OY · 2010 · cites it directly1descendant
- K242161Radlink GPS Pro ImagingRadlink, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −4 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −3 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −2 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| −1 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| 0 (this device) | K083645 | Radstar Family, Models: Radstar 4343 & Variations | 5 Star Medical, Inc. | 2009 | — |
| +1 | K131211 | Dicompacs DX-R with Flat Panel | Oehm Und Rehbein GmbH | 2013 | — |
| +2 | K141440 | Dicompacs DX-R with Flat Panel | Oehm Und Rehbein GmbH | 2014 | — |
| +3 | K142718 | Radlink GPS | Radlink, Inc. | 2014 | — |
| +1 | K101435 | Imix Panorad and Somarad | Imix Adr Finland OY | 2010 | — |
| +4 | 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 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K081648 | Digital Radiography Cxdi-60GSummary page 1…tact: Terry L. Ancar October 30, 20_08 RadStar Digital Imaging System FEB 3 4 2009 Solid State X-ray Imager (Flat Panel/Digital Imager) MQB at 21 CFR Part 892.1650 K081648 Canon CXDI-60G K024147 Varian PaxScan 4030 The RadStar Digital Imaging System consists of two components, a solid state x-ray i… | 2008 |
| * | K024147 | Paxscan 4030 Medical Digital Imaging SystemSummary page 1…tober 30, 20_08 RadStar Digital Imaging System FEB 3 4 2009 Solid State X-ray Imager (Flat Panel/Digital Imager) MQB at 21 CFR Part 892.1650 K081648 Canon CXDI-60G K024147 Varian PaxScan 4030 The RadStar Digital Imaging System consists of two components, a solid state x-ray imager and software for v… | 2003 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 28 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 10 of the 22 ancestors have a recall of any class.
- Of its descendants, K131211 (Oehm Und Rehbein GmbH, 2013) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K081648.
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. 2009, 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?
The RadStar DDR Digital Imaging System is intended for use in generating radiographic images of human anatomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. This device is intended for incorporation into a complete x-ray system by qualified x-ray service personnel. This device is not intended for mammography applications. This device is intended for use by qualified medical personnel and is contraindicated when, in the judgment of the physician, procedures would be contrary to the best interest of the patient.
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/K083645 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083645: Radstar Family, Models: Radstar 4343 & Variations.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083645
Report an extraction error
Are you the manufacturer?
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