510(k) · Cleared
ClearedInsight Agile DRF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imaging Engineering, LLC · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Jul 27, 2021 as substantially equivalent to K191503 (Portavision Medical, LLC, 2019) after a 161-day review. Its family tree reaches back 5 generations to 1997. 1 of the 9 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jul 27, 2021
- Review
- 161 days
- Class
- Class II
- Product code
- JAA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K973598 (1997). 7 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 4 generations backK022114 ImperiumElmstech, Inc. · 2002
- 3 generations backK032761 KMC-950 C-Arm Mobile SystemUnited Radiology Systems, Inc. · 2004
- 2 generations backK160279 ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd. · 2016
- 1 generation backK191503 MobileRay Pulse SE Digital Imaging SystemPortavision Medical, LLC · 2019
- This deviceK210469 Insight Agile DRFImaging Engineering, LLC · 2021
- Descendant · cites it directly · 0 of its ownK242731 MasteRad MiniX Mobile Digital Imaging System (Mini-X)Medicatech USA, Inc. · 2025
Class I recalls in this family
- K021049 Oec 9800 Plus Digital Mobile Imaging System4 generations back · 2002
Most influential descendants
Showing 1 of 1 · See all- K242731MasteRad MiniX Mobile Digital Imaging System (Mini-X)Medicatech USA, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −4 | K022114 | Imperium | Elmstech, Inc. | 2002 | — |
| −3 | K032761 | KMC-950 C-Arm Mobile System | United Radiology Systems, Inc. | 2004 | — |
| −2 | K160279 | ANYVIEW-500R Fluoroscopic Mobile X-Ray System | Ecotron Co., Ltd. | 2016 | — |
| −1 | K191503 | MobileRay Pulse SE Digital Imaging System | Portavision Medical, LLC | 2019 | — |
| 0 (this device) | K210469 | Insight Agile DRF | Imaging Engineering, LLC | 2021 | — |
| +1 | K242731 | MasteRad MiniX Mobile Digital Imaging System (Mini-X) | Medicatech USA, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K191503 | MobileRay Pulse SE Digital Imaging SystemSummary page 4…lass: Class II Product Code: JAA, OXO, RCC and QHY Common/Usual Name: Mobile Fluoroscopic System 2. Predicate Device: K191503 Trade Name: MobileRay Pulse SE Digital Imaging System Manufacturer: PortaVision Medical, LLC… | 2019 |
| † | K200396 | Insight Enhanced DRF Digital Imaging System | 2020 |
| † | K202722 | 1212FCA | 2020 |
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 |
|---|---|---|---|
| K242731 | MasteRad MiniX Mobile Digital Imaging System (Mini-X) | 2025 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K021049Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · 4 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 7 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K242731 (Medicatech USA, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K191503.
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. 2021, 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 Insight Agile DRF is intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device provides fluoroscopic imaging and is used for guidance and visualization during routine fluoroscopic and image-guided procedures. The device is to be used in professional healthcare facilities, in a variety of image-guided…
Read the full statement (122 words)
The Insight Agile DRF is intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device provides fluoroscopic imaging and is used for guidance and visualization during routine fluoroscopic and image-guided procedures. The device is to be used in professional healthcare facilities, in a variety of image-guided procedures such as feeding tube and catheter insertion on pediatric patients and neonates (birth to one month). This device is not indicated for large/obese patients or interventional use. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications. (Rx Only)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210469 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210469: Insight Agile DRF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210469
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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