510(k) · Cleared
ClearedAmrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Summit Industries, LLC · KPR System, X-Ray, Stationary
Cleared on Mar 14, 2016 as substantially equivalent to K121513 (Siemens Medical Solution, 2012) after a 137-day review. Its family tree reaches back 10 generations to 1980. 2 later devices descend from it.
- Decided
- Mar 14, 2016
- Review
- 137 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K801623 (1980). 65 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 6 generations between
- 3 generations backK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 2 generations backK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 1 generation backK121513 Multix FusionSiemens Medical Solution · 2012 · Recalled
- This deviceK153119 Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS…Summit Industries, LLC · 2016
- Descendant · cites it directly · 0 of its ownK183541 ProRad 2FC and ProRad 3NC Stationary Radiographic SystemsPrognosys Medical Systems Private Limited · 2019
- Descendant · cites it directly · 0 of its ownK173823 Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus…Summit Industries, LLC · 2018
Show all 10 generations
- Root · 10 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 9 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 8 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 7 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 6 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 5 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 4 generations backK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 3 generations backK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 2 generations backK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 1 generation backK121513 Multix FusionSiemens Medical Solution · 2012 · Recalled
- This deviceK153119 Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS…Summit Industries, LLC · 2016
Most influential descendants
Showing 2 of 2 · See all- K183541ProRad 2FC and ProRad 3NC Stationary Radiographic SystemsPrognosys Medical Systems Private Limited · 2019 · cites it directly0descendants
- K173823Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography…Summit Industries, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −9 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −8 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −7 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −6 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −5 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −4 | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −3 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| −2 | K081722 | YSIO | Siemens Medical Solutions USA, Inc. | 2008 | 11 |
| −1 | K121513 | Multix Fusion | Siemens Medical Solution | 2012 | 4 |
| 0 (this device) | K153119 | Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital… | Summit Industries, LLC | 2016 | — |
| +1 | K183541 | ProRad 2FC and ProRad 3NC Stationary Radiographic Systems | Prognosys Medical Systems Private Limited | 2019 | — |
| +1 | K173823 | Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital… | Summit Industries, LLC | 2018 | — |
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 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K121513 | Multix FusionSummary page 4…: Class II Product Code: KPR 4. Legally Marketed Predicate Device Trade Name: Multix Fusion 510(k) #: K121513 Clearance Date: August 10, 2012 Classification Name: Stationary X-Ray System Classification Panel: Ra… | 2012 |
What descends from it? (2)
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 36 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 20 of the 65 ancestors have a recall of any class.
- Of its descendants, K183541 (Prognosys Medical Systems Private Limited, 2019) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K121513.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
These radiographic systems are intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography, angiography, interventional, or fluoroscopy use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153119: Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153119
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