510(k) · Cleared
ClearedUniscan, Pulmoscan, Pulmoscan Radiographic Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medlink Imaging · KPR System, X-Ray, Stationary
Cleared on Mar 18, 2005 as substantially equivalent to K983732 (Siemens Medical Solutions USA, Inc., 1999) after a 491-day review. Its family tree reaches back 3 generations to 1981.
- Decided
- Mar 18, 2005
- Review
- 491 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K803130 (1981). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 2 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 1 generation backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- This deviceK033577 Uniscan, Pulmoscan, Pulmoscan Radiographic SystemsMedlink Imaging · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −2 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −1 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| 0 (this device) | K033577 | Uniscan, Pulmoscan, Pulmoscan Radiographic Systems | Medlink Imaging | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1992 | 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 KPR? 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 KPR device
- #1 K242119 Innovision-Exiiscore 17.0 · 9 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 |
|---|---|---|---|
| * | K983732 | Thorax FD and Multix FDSummary page 1…or Transportable X-Ray System . Equivalent legally marketed devices This product is similar in function to the Siemens Multix FD and Thorax FD Stationary X-Ray System (K983732) _ Indications for Use (intended use) - The “Uniscan™ model is a stationary general-purpose diagnostic (universal) system for ob… | 1999 |
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 24 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- 4 of the 5 ancestors have a recall of any class.
- 3 other devices also cite its predicate K983732.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPR
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPR
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPR
7in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPR
39in 2025
MAUDE reports naming product code KPR, 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 | 12 | 31 | 10 | 120 |
| 2008 | 15 | 48 | 10 | 95 |
| 2009 | 9 | 35 | 5 | 61 |
| 2010 | 9 | 126 | 3 | 82 |
| 2011 | 9 | 152 | 5 | 103 |
| 2012 | 11 | 58 | 1 | 74 |
| 2013 | 5 | 163 | 5 | 24 |
| 2014 | 10 | 108 | 8 | 34 |
| 2015 | 18 | 81 | 1 | 59 |
| 2016 | 11 | 84 | 4 | 18 |
| 2017 | 6 | 75 | 3 | 31 |
| 2018 | 15 | 30 | 4 | 36 |
| 2019 | 12 | 33 | 1 | 77 |
| 2020 | 16 | 39 | 1 | 41 |
| 2021 | 6 | 55 | 0 | 37 |
| 2022 | 8 | 43 | 2 | 27 |
| 2023 | 9 | 76 | 4 | 39 |
| 2024 | 11 | 162 | 1 | 34 |
| 2025 | 8 | 155 | 7 | 39 |
| 2026 | 6 | 197 | 0 | — |
What is it indicated for?
The DRS system of the “Uniscan” model is a stationary general-purpose diagnostic (universal) system for obtaining standard planar X-ray images of the bone structure and soft tissues of a patient in the standing, sitting and lying position The DRS system of the “Pulmoscan” model is a stationary specialized-purpose diagnostic system for mass examination (screening) of wide groups of population, first of all, in polyclinics at the stage of before-doctor…
Read the full statement (144 words)
The DRS system of the “Uniscan” model is a stationary general-purpose diagnostic (universal) system for obtaining standard planar X-ray images of the bone structure and soft tissues of a patient in the standing, sitting and lying position
The DRS system of the “Pulmoscan” model is a stationary specialized-purpose diagnostic system for mass examination (screening) of wide groups of population, first of all, in polyclinics at the stage of before-doctor examination with the purpose of carly diagnostics of the thorax organs.
The DRS system of the “pulmoscan-T" model is a mobile specialized-purposc diagnostic system, particularly, for mass examination (screening) of widc groups of population directly at the places of their maximum concentration (in educational institutions and at enterprises), in remote arcas (villages, military units), in institutions with the special access regime (refugees camps, penal jurisdiction) with the purposc of early diagnostics of the thorax organs.
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/K033577 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033577: Uniscan, Pulmoscan, Pulmoscan Radiographic Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033577
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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