510(k) · Cleared
ClearedInsight Enhanced DRF Digital Imaging System
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 Mar 6, 2020 as substantially equivalent to K191310 (Imaging Engineering, LLC, 2019) after a 17-day review. Its family tree reaches back 4 generations to 1991. 1 later device descends from it.
- Decided
- Mar 6, 2020
- Review
- 17 days
- Class
- Class II
- Product code
- JAA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K911454 (1991). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK911454 FC2000S & S Inficon, Inc. · 1991
- 3 generations backK012490 Orion Digital Imaging SystemInfimed, Inc. · 2002
- 2 generations backK070390 Fluoropro RF Digital Imaging SystemVirtual Imaging, Inc. · 2007
- 1 generation backK191310 Insight Essentials DRF Digital Imaging SystemImaging Engineering, LLC · 2019
- This deviceK200396 Insight Enhanced DRF Digital Imaging SystemImaging Engineering, LLC · 2020
- Descendant · cites it directly · 0 of its ownK251650 Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLC · 2025
Most influential descendants
Showing 1 of 1 · See all- K251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911454 | FC2000 | S & S Inficon, Inc. | 1991 | — |
| −3 | K012490 | Orion Digital Imaging System | Infimed, Inc. | 2002 | — |
| −2 | K070390 | Fluoropro RF Digital Imaging System | Virtual Imaging, Inc. | 2007 | — |
| −1 | K191310 | Insight Essentials DRF Digital Imaging System | Imaging Engineering, LLC | 2019 | — |
| 0 (this device) | K200396 | Insight Enhanced DRF Digital Imaging System | Imaging Engineering, LLC | 2020 | — |
| +1 | K251650 | Insight Enhanced™ DRF (EN-1002-01) | Imaging Engineering, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
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.
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 |
|---|---|---|---|
| * | K191310 | Insight Essentials DRF Digital Imaging SystemSummary page 4…Class II Product Code: JAA and LLZ Predicate Device Trade Name: Insight Essentials™ DRF Digital Imaging System 510(k) Clearance #: K191310 Clearance date: 06/10/2019 Classification Name: Image Intensified Fluoroscopic X-ray System Classification P… | 2019 |
| † | K180473 | ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR… | 2018 |
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 |
|---|---|---|---|
| K251650 | Insight Enhanced™ DRF (EN-1002-01) | 2025 | 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 29 years and passes through 4 companies; a new generation was cleared every 10.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K251650 (Imaging Engineering, LLC, 2025) 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. 2020, 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?
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for
obtaining fluoroscopic radiographic images of the skull, spinal column, chest, abdomen, extremities,
and other body parts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200396 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200396: Insight Enhanced DRF Digital Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200396
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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