510(k) · Cleared
ClearedInsight Enhanced™ DRF (EN-1002-01)
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 Sep 16, 2025 as substantially equivalent to K200396 (Imaging Engineering, LLC, 2020) and 1 other predicate after a 110-day review. Its family tree reaches back 6 generations to 2002. 2 of the 14 devices in its family, counting itself, have a Class I recall.
- Decided
- Sep 16, 2025
- Review
- 110 days
- Class
- Class II
- Product code
- JAA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K021049 (2002). 13 ancestors in all, the oldest K911454 (1991). No later device cites it as a predicate yet. 2 of the 14 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK021049 Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · Recalled (Class I)
- 5 generations backK041932 Oec Olympus Fluoroscopic Imaging SystemGe Oec Medical Systems, Inc. · 2004 · Recalled
- 4 generations backK073543 Oec 9900 EliteGe Oec Medical Systems · 2008 · Recalled
- 3 generations backK082781 Oec 9900 EliteGe Healthcare Surgery · 2009 · Recalled
- 2 generations backK111551 Oec (R) 9800, Oec (R) 9800 PlusGe Oec Medical Systems, Inc. · 2011 · Recalled
- 1 generation backK132027 Oec 9800 PlusGe Oec Medical Systems, Inc. · 2014 · Recalled
- This deviceK251650 Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLC · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K021049 | Oec 9800 Plus Digital Mobile Imaging System | Ge Oec Medical Systems | 2002 | Class I |
| −5 | K041932 | Oec Olympus Fluoroscopic Imaging System | Ge Oec Medical Systems, Inc. | 2004 | 7 |
| −4 | K073543 | Oec 9900 Elite | Ge Oec Medical Systems | 2008 | 5 |
| −3 | K082781 | Oec 9900 Elite | Ge Healthcare Surgery | 2009 | 4 |
| −2 | K111551 | Oec (R) 9800, Oec (R) 9800 Plus | Ge Oec Medical Systems, Inc. | 2011 | 9 |
| −1 | K132027 | Oec 9800 Plus | Ge Oec Medical Systems, Inc. | 2014 | 8 |
| 0 (this device) | K251650 | Insight Enhanced™ DRF (EN-1002-01) | Imaging Engineering, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2007 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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.
2 devices in this family have 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? (2)
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.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 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.
- K024012Oec 9800 E/CV+ Digital Mobile Imaging SystemGe Oec Medical Systems · 2003 · 5 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K021049Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 7 of the 13 ancestors have a recall of any class; 2 have a Class I recall.
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. 2025, 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 physician or technician for obtaining fluoroscopic and radiographic images of the skull, spinal column, chest, abdomen, and extremities in adult and pediatric patients. Rx only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251650 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251650: Insight Enhanced™ DRF (EN-1002-01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251650
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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