510(k) · Cleared
ClearedProRad 2FC and ProRad 3NC Stationary Radiographic Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prognosys Medical Systems Private Limited · KPR System, X-Ray, Stationary
Cleared on Jan 24, 2019 as substantially equivalent to K150816 (Sg Healthcare Co, Ltd., 2015) and 1 other predicate after a 35-day review. Its family tree reaches back 11 generations to 1980.
- Decided
- Jan 24, 2019
- Review
- 35 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K801623 (1980). 78 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 7 generations between
- 3 generations backK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 2 generations backK121513 Multix FusionSiemens Medical Solution · 2012 · Recalled
- 1 generation backK153119 Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS…Summit Industries, LLC · 2016
- This deviceK183541 ProRad 2FC and ProRad 3NC Stationary Radiographic SystemsPrognosys Medical Systems Private Limited · 2019
Show all 11 generations
- Root · 11 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 10 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 9 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 8 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 7 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 6 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 5 generations backK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 4 generations backK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 3 generations backK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 2 generations backK121513 Multix FusionSiemens Medical Solution · 2012 · Recalled
- 1 generation backK153119 Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS…Summit Industries, LLC · 2016
- This deviceK183541 ProRad 2FC and ProRad 3NC Stationary Radiographic SystemsPrognosys Medical Systems Private Limited · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −10 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −9 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −8 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −7 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −6 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −5 | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −4 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| −3 | K081722 | YSIO | Siemens Medical Solutions USA, Inc. | 2008 | 11 |
| −2 | K121513 | Multix Fusion | Siemens Medical Solution | 2012 | 4 |
| −1 | K153119 | Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital… | Summit Industries, LLC | 2016 | — |
| 0 (this device) | K183541 | ProRad 2FC and ProRad 3NC Stationary Radiographic Systems | Prognosys Medical Systems Private Limited | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 13 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 7 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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? (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 |
|---|---|---|---|
| * | K150816 | Jumong SeriesSummary page 4…lass: Class II Product Code: KPR, MQB Predicate Device: 1. Jumong Series Stationary Radiographic System (K150816) 2. Amrad Medical OTS Digital Radiography System, Amrad Medic… | 2015 |
| * | K153119 | Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography…Summary page 4…Amrad Medical DFMTS Digital Radiography System, Amrad Medical FRS Digital Radiography System (K153119) Indications for Use: The ProRad Series Stationary Radiographic System is intended for use by a qualified, trained doctor or te… | 2016 |
| † | K103591 | Digital Radiography | 2011 |
| † | K171270 | Digital Radiography Cxdi-410C Wireless | 2017 |
| † | K131106 | Digital Radiography Cxdi-701C Wireless, Digital Radiography Cxdi-70IG Wireless, Digital… | 2013 |
| † | K170332 | Digital Radiography Cxdi-710C Wireless, Digital Radiography Cxdi-810C Wireless | 2017 |
| † | K172951 | Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) | 2017 |
| † | K161459 | Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) | 2016 |
| † | K142698 | PerkinElmer, XRpad 4343 F MED Flat Panel Detector | 2014 |
| † | K140551 | Perkinelmer, Xrpad 4336 Med Flat Panel Detector | 2014 |
| † | K162555 | Evs 4343, Evs 4343G | 2016 |
| † | K162552 | Evs 3643, Evs 3643G | 2016 |
| † | K153312 | Scatter Correction for Cxdi Series | 2016 |
| † | K130883 | Sedecal Digital Radiographic Upgrade Model Sdru-T | 2013 |
| † | K152172 | Econsole1 | 2015 |
| † | K122865 | Vivix-S Wireless | 2013 |
| † | K122866 | Vivix-S with Vxvue | 2013 |
| † | K120020 | Vivix-S | 2012 |
| † | K130318 | Nexus DRF Digital X-Ray Imaging System (with Paxscan 4343CB) | 2013 |
| † | K152767 | OTC12D Auto Radiographic System | 2015 |
| † | K173823 | Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography… | 2018 |
| † | K103050 | DX-D 300 | 2010 |
| † | K188187 | X-ray tube |
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 39 years and passes through 8 companies; a new generation was cleared every 2.0 years on median.
- 22 of the 78 ancestors have a recall of any class.
- 1 other device also cites its predicate K150816.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
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?
ProRad Series Stationary Radiographic System is intended for use by a qualified, trained doctor or technician on both adult and paediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. 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/K183541 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183541: ProRad 2FC and ProRad 3NC Stationary Radiographic Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183541
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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