510(k) · Cleared
ClearedPlatinum dRF Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apelem-Dms Group · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Mar 4, 2016 as substantially equivalent to K131766 (Apelem-Dms Group, 2013) after a 29-day review. Its family tree reaches back 9 generations to 1980. 1 later device descends from it.
- Decided
- Mar 4, 2016
- Review
- 29 days
- Class
- Class II
- Product code
- JAA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K801623 (1980). 57 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 5 generations between
- 3 generations backK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 2 generations backK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 1 generation backK131766 Platinum DRF Imaging SystemApelem-Dms Group · 2013
- This deviceK160301 Platinum dRF Imaging SystemApelem-Dms Group · 2016
- Descendant · cites it directly · 0 of its ownK203010 Platinum dRF Imaging SystemApelem-Dms Group · 2021
Show all 9 generations
- Root · 9 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 8 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 7 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 6 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 5 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 4 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 3 generations backK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 2 generations backK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 1 generation backK131766 Platinum DRF Imaging SystemApelem-Dms Group · 2013
- This deviceK160301 Platinum dRF Imaging SystemApelem-Dms Group · 2016
Most influential descendants
Showing 1 of 1 · See all- K203010Platinum dRF Imaging SystemApelem-Dms Group · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −8 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −7 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −6 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −5 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −4 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −3 | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −2 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| −1 | K131766 | Platinum DRF Imaging System | Apelem-Dms Group | 2013 | — |
| 0 (this device) | K160301 | Platinum dRF Imaging System | Apelem-Dms Group | 2016 | — |
| +1 | K203010 | Platinum dRF Imaging System | Apelem-Dms Group | 2021 | — |
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 | 1 | 0 |
| 1995 | 12 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 JAA? 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 JAA device
- #1 K253103 Nexus DRF Digital X-ray Imaging Systemscore 13.2 · 7 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 |
|---|---|---|---|
| * | K131766 | Platinum DRF Imaging SystemSummary page 4…Device Class: Class II Regulation and: 21 CFR 892.1650 Product code: JAA Classification panel: Radiology C) Predicate: K131766 Apelem-DMS Platinum dRF Imaging System D) Date Prepared: February 1, 2016 E) Device Description The Apelem-DMS Platinu… | 2013 |
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 |
|---|---|---|---|
| K203010 | Platinum dRF Imaging System | 2021 | 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 36 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 18 of the 57 ancestors have a recall of any class.
- Of its descendants, K203010 (Apelem-Dms Group, 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JAA devicesJAA System, X-Ray, Fluoroscopic, Image-Intensified: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · JAA
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAA
89in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAA
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAA
33in 2025
MAUDE reports naming product code JAA, 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 | 1 | — | 35 | 9,517 |
| 2008 | 6 | 18 | 21 | 9,484 |
| 2009 | 0 | — | 18 | 12,040 |
| 2010 | 1 | — | 6 | 5,803 |
| 2011 | 4 | 48 | 7 | 14,000 |
| 2012 | 1 | — | 2 | 11,684 |
| 2013 | 6 | 129 | 3 | 13,706 |
| 2014 | 6 | 276 | 1 | 10,265 |
| 2015 | 3 | 197 | 1 | 2,922 |
| 2016 | 2 | — | 7 | 35 |
| 2017 | 1 | — | 3 | 56 |
| 2018 | 3 | 30 | 1 | 36 |
| 2019 | 6 | 49 | 2 | 49 |
| 2020 | 4 | 39 | 2 | 39 |
| 2021 | 6 | 104 | 2 | 35 |
| 2022 | 1 | — | 5 | 34 |
| 2023 | 2 | — | 9 | 41 |
| 2024 | 3 | 89 | 2 | 25 |
| 2025 | 2 | — | 4 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Platinum dRF Imaging System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, diagnostic fluoroscopy, conventional linear tomography, angiography and pediatric examinations. The Platinum dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.…
Read the full statement (145 words)
The Platinum dRF Imaging System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, diagnostic fluoroscopy, conventional linear tomography, angiography and pediatric examinations.
The Platinum dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited to gastrointestinal examinations, cranial, skeletal, thoracic and lung exposures as well as examination of the urogenital tract. The units may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, digital angiography and digital subtraction angiography (DSA).
The Platinum dRF may be used for outpatient and emergency treatment, as well as for mobile transport (wheelchair and bed) examinations.
The Platinum dRF is not indicated for use in interventional radiology.
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/K160301 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160301: Platinum dRF Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160301
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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