510(k) · Cleared
ClearedExtron 5; Extron 7
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DRTECH Corporation · OWB Interventional Fluoroscopic X-Ray System
Cleared on Aug 17, 2023 as substantially equivalent to K142708 (Philips Medical Systems Nethrlands BV, 2014) after a 140-day review. Its family tree reaches back 5 generations to 2004. 3 later devices descend from it.
- Decided
- Aug 17, 2023
- Review
- 140 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K042646 (2004). 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK042646 DynactSiemens Medical Systems, Inc. · 2004
- 4 generations backK061685 PulseraPhilips Medical Systems North America Co. · 2006
- 3 generations backK090590 Veradius, Model 718-130Philips Medical Systems North America Co. · 2009
- 2 generations backK133819 VeradiusPhilips Medical Systems Nederland B.V. · 2014
- 1 generation backK142708 Veradius UnityPhilips Medical Systems Nethrlands BV · 2014 · Recalled
- This deviceK230871 Extron 5; Extron 7DRTECH Corporation · 2023
- Descendant · cites it directly · 1 of its ownK250010 Extron 3; Extron 5; Extron 7DRTECH Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK261413 Extron 3;Extron 6DRTECH Corporation · 2026
- Descendant · cites it directly · 0 of its ownK251893 Skan C PulsarSkanray Technologies Limited · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K042646 | Dynact | Siemens Medical Systems, Inc. | 2004 | — |
| −4 | K061685 | Pulsera | Philips Medical Systems North America Co. | 2006 | — |
| −3 | K090590 | Veradius, Model 718-130 | Philips Medical Systems North America Co. | 2009 | — |
| −2 | K133819 | Veradius | Philips Medical Systems Nederland B.V. | 2014 | — |
| −1 | K142708 | Veradius Unity | Philips Medical Systems Nethrlands BV | 2014 | 4 |
| 0 (this device) | K230871 | Extron 5; Extron 7 | DRTECH Corporation | 2023 | — |
| +1 | K250010 | Extron 3; Extron 5; Extron 7 | DRTECH Corporation | 2025 | — |
| +2 | K261413 | Extron 3;Extron 6 | DRTECH Corporation | 2026 | — |
| +1 | K251893 | Skan C Pulsar | Skanray Technologies Limited | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 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 OWB? 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 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 |
|---|---|---|---|
| * | K142708 | Veradius UnitySummary page 5…1/7 4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)] • 510(k) Number: K142708 • Applicant: GENERAL ELECTRIC COMPANY • Trade Name: VERADIUS UNITY • Classification… | 2014 |
What descends from it? (3)
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 19 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K250010 (DRTECH Corporation, 2025) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K142708.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
EXTRON5 and EXTRON 7 are a mobile fluoroscopic X-ray system with high output capacity, high thermal capacity and high resolution image processing system, which provides X-ray images of the patient's anatomy during surgery or treatment. This device plays an important role in emergency injury treatment, orthopedic surgery, neurosurgery surgery, bone surgery, etc. This device has a function to save important a specific images as records, so you can easily…
Read the full statement (113 words)
EXTRON5 and EXTRON 7 are a mobile fluoroscopic X-ray system with high output capacity, high thermal capacity and high resolution image processing system, which provides X-ray images of the patient's anatomy during surgery or treatment. This device plays an important role in emergency injury treatment, orthopedic surgery, neurosurgery surgery, bone surgery, etc. This device has a function to save important a specific images as records, so you can easily search for the images and transmit it to the PACS system in the hospital to help the medical staff in diagnosis.
Examples of a clinical application may include: Neurosurgery, Orthopedics, Anesthesiology, Urology, Gynecology, Internal Medicine
(※ This device is not intended for mammography applications.)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230871 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230871: Extron 5; Extron 7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230871
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