510(k) · Cleared
Recalled · Class II · 2021AMX Navigate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · IZL System, X-Ray, Mobile
Cleared on Apr 28, 2021 as substantially equivalent to K182234 (Ge Medical Systems, LLC, 2018) after a 27-day review. Its family tree reaches back 9 generations to 1994. It has been recalled once.
- Decided
- Apr 28, 2021
- Review
- 27 days
- Class
- Class II
- Product code
- IZL
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 9 generations to K931071 (1994). 16 ancestors in all, the oldest K802047 (1980). No later device cites it as a predicate yet.
- Root · 9 generations backK931071 Philips ThoravisionPhilips Medical Systems, Inc. · 1994 · Recalled
- 5 generations between
- 3 generations backK162990 Optima XR240amxGe Medical Systems, LLC · 2016 · Recalled
- 2 generations backK173602 Optima XR240amx, AutoGridGe Medical Systems, LLC · 2018 · Recalled
- 1 generation backK182234 Optima XR240amxGe Medical Systems, LLC · 2018 · Recalled
- This deviceK210982 AMX NavigateGe Medical Systems, LLC · 2021
Show all 9 generations
- Root · 9 generations backK931071 Philips ThoravisionPhilips Medical Systems, Inc. · 1994 · Recalled
- 8 generations backK982795 Philips Bucky VisionPhilips Medical Systems, Inc. · 1998 · Recalled
- 7 generations backK090625 Wireless Portable Detector FD-W17Philips Medical Systems North America Co. · 2009 · Recalled
- 6 generations backK102615 Wireless DR Imaging Option-WDR1Ge Medical Systems, LLC · 2010 · Recalled
- 5 generations backK103476 BRIVOXR285AMX, Optima XR200AMX, OPTIMAXR220AMXGe Medical Systems, LLC · 2011 · Recalled
- 4 generations backK142383 Optima XR200amx, Optima XR220amxGe Medical Systems, LLC · 2014 · Recalled
- 3 generations backK162990 Optima XR240amxGe Medical Systems, LLC · 2016 · Recalled
- 2 generations backK173602 Optima XR240amx, AutoGridGe Medical Systems, LLC · 2018 · Recalled
- 1 generation backK182234 Optima XR240amxGe Medical Systems, LLC · 2018 · Recalled
- This deviceK210982 AMX NavigateGe Medical Systems, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K931071 | Philips Thoravision | Philips Medical Systems, Inc. | 1994 | 1 |
| −8 | K982795 | Philips Bucky Vision | Philips Medical Systems, Inc. | 1998 | 17 |
| −7 | K090625 | Wireless Portable Detector FD-W17 | Philips Medical Systems North America Co. | 2009 | 28 |
| −6 | K102615 | Wireless DR Imaging Option-WDR1 | Ge Medical Systems, LLC | 2010 | 1 |
| −5 | K103476 | BRIVOXR285AMX, Optima XR200AMX, OPTIMAXR220AMX | Ge Medical Systems, LLC | 2011 | 8 |
| −4 | K142383 | Optima XR200amx, Optima XR220amx | Ge Medical Systems, LLC | 2014 | 8 |
| −3 | K162990 | Optima XR240amx | Ge Medical Systems, LLC | 2016 | 2 |
| −2 | K173602 | Optima XR240amx, AutoGrid | Ge Medical Systems, LLC | 2018 | 2 |
| −1 | K182234 | Optima XR240amx | Ge Medical Systems, LLC | 2018 | 2 |
| 0 (this device) | K210982 | AMX Navigate | Ge Medical Systems, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1986 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 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 IZL? 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 IZL device
- #1 K242015 TOPAZ Mobile X-ray System (Models : TOPAZ-32D…score 19.9 · 19 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 |
|---|---|---|---|
| * | K182234 | Optima XR240amxSummary page 5…Page 2 GE Healthcare 510(k) Premarket Notification Submission Predicate Optima XR240amx with RFID (K182234) Device(s): Regulation Name: Mobile X-Ray System Regulation: 21 CFR 892.1720… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 24, 2021 | Class II | Z-2590-2021 | Process control | An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 12 of the 16 ancestors have a recall of any class.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · IZL
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZL
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZL
47in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZL
27in 2025
MAUDE reports naming product code IZL, 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 | 30 | 7 | 16 |
| 2008 | 4 | 49 | 0 | 27 |
| 2009 | 3 | 125 | 0 | 35 |
| 2010 | 3 | 65 | 4 | 75 |
| 2011 | 6 | 66 | 6 | 118 |
| 2012 | 3 | 83 | 5 | 24 |
| 2013 | 0 | — | 10 | 17 |
| 2014 | 7 | 104 | 4 | 51 |
| 2015 | 4 | 88 | 4 | 30 |
| 2016 | 6 | 47 | 0 | 33 |
| 2017 | 7 | 45 | 0 | 35 |
| 2018 | 8 | 47 | 0 | 27 |
| 2019 | 9 | 33 | 2 | 40 |
| 2020 | 9 | 43 | 1 | 48 |
| 2021 | 13 | 48 | 0 | 47 |
| 2022 | 16 | 89 | 1 | 32 |
| 2023 | 3 | 55 | 6 | 77 |
| 2024 | 9 | 159 | 5 | 39 |
| 2025 | 11 | 153 | 47 | 27 |
| 2026 | 6 | 157 | 5 | — |
What is it indicated for?
The AMX Navigate is intended to take exposures utilizing film, computed radiography (CR), or wireless detectors, which are intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR). AMX Navigate is a self-contained; battery operated mobile radiographic imaging system designed to generate diagnostic radiographic images (medical x-rays) that may increase the ability to detect disease or…
Read the full statement (260 words)
The AMX Navigate is intended to take exposures utilizing film, computed radiography (CR), or wireless detectors, which are intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).
AMX Navigate is a self-contained; battery operated mobile radiographic imaging system designed to generate diagnostic radiographic images (medical x-rays) that may increase the ability to detect disease or injury early enough for a medical problem to be managed, treated, or cured. Medical x-rays are used in many types of examinations and procedures, some examples include: x-ray radiography (to find orthopedic damage, tumors, pneumonias, foreign objects).
The AMX Navigate is indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. Its mobility enables general-purpose radiographic procedures throughout the clinical environment, or as needed within the emergency, intensive care, premature birth ward, cardiac and operating departments, for patients that may not be able to be moved or in cases where it is unsafe or impractical to move them to a traditional RAD room.
The system is indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine position.
This device is not intended for mammographic applications.
The AMX Navigate incorporates AutoGrid, which is an optional image processing software installed as a part of the systems Helix image processing software. AutoGrid can be used in lieu of an anti-scatter grid to improve image contrast in general radiographic images by reducing the effects of scatter radiation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210982 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210982: AMX Navigate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210982
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