510(k) · Cleared
Recalled · Class II · 2026BRIVOXR285AMX, Optima XR200AMX, OPTIMAXR220AMX
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 Jun 16, 2011 as substantially equivalent to K021016 (GE Medical Systems, 2002) and 2 other predicates after a 204-day review. Its family tree reaches back 4 generations to 1994. 5 later devices descend from it. It has been recalled 8 times.
- Decided
- Jun 16, 2011
- Review
- 204 days
- Class
- Class II
- Product code
- IZL
- Recalls
- 8
- Predicates
- 3
Its longest line of descent runs back 4 generations to K931071 (1994). 11 ancestors in all, the oldest K802047 (1980). 5 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK931071 Philips ThoravisionPhilips Medical Systems, Inc. · 1994 · Recalled
- 3 generations backK982795 Philips Bucky VisionPhilips Medical Systems, Inc. · 1998 · Recalled
- 2 generations backK090625 Wireless Portable Detector FD-W17Philips Medical Systems North America Co. · 2009 · Recalled
- 1 generation backK102615 Wireless DR Imaging Option-WDR1Ge Medical Systems, LLC · 2010 · Recalled
- This deviceK103476 BRIVOXR285AMX, Optima XR200AMX, OPTIMAXR220AMXGe Medical Systems, LLC · 2011
- Descendant · cites it directly · 4 of its ownK142383 Optima XR200amx, Optima XR220amxGe Medical Systems, LLC · 2014 · Recalled
- Descendant · 2 generations on · 3 of its ownK162990 Optima XR240amxGe Medical Systems, LLC · 2016 · Recalled
- Descendant · 3 generations on · 2 of its ownK173602 Optima XR240amx, AutoGridGe Medical Systems, LLC · 2018 · Recalled
- Descendant · 4 generations on · 1 of its ownK182234 Optima XR240amxGe Medical Systems, LLC · 2018 · Recalled
- Descendant · 5 generations on · 0 of its ownK210982 AMX NavigateGe Medical Systems, LLC · 2021 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K142383Optima XR200amx, Optima XR220amxGe Medical Systems, LLC · 2014 · cites it directly4descendants
- K162990Optima XR240amxGe Medical Systems, LLC · 2016 · 2 generations on3descendants
- K173602Optima XR240amx, AutoGridGe Medical Systems, LLC · 2018 · 3 generations on2descendants
- K182234Optima XR240amxGe Medical Systems, LLC · 2018 · 4 generations on1descendant
- K210982AMX NavigateGe Medical Systems, LLC · 2021 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K931071 | Philips Thoravision | Philips Medical Systems, Inc. | 1994 | 1 |
| −3 | K982795 | Philips Bucky Vision | Philips Medical Systems, Inc. | 1998 | 17 |
| −2 | K090625 | Wireless Portable Detector FD-W17 | Philips Medical Systems North America Co. | 2009 | 28 |
| −1 | K102615 | Wireless DR Imaging Option-WDR1 | Ge Medical Systems, LLC | 2010 | 1 |
| 0 (this device) | K103476 | BRIVOXR285AMX, Optima XR200AMX, OPTIMAXR220AMX | Ge Medical Systems, LLC | 2011 | — |
| +1 | K142383 | Optima XR200amx, Optima XR220amx | Ge Medical Systems, LLC | 2014 | 8 |
| +2 | K162990 | Optima XR240amx | Ge Medical Systems, LLC | 2016 | 2 |
| +3 | K173602 | Optima XR240amx, AutoGrid | Ge Medical Systems, LLC | 2018 | 2 |
| +4 | K182234 | Optima XR240amx | Ge Medical Systems, LLC | 2018 | 2 |
| +5 | K210982 | AMX Navigate | Ge Medical Systems, LLC | 2021 | 1 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2021 | 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? (3)
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 |
|---|---|---|---|
| * | K021016 | Amx-4 Plus Mobile X-Ray SystemSummary page 1…0amx ; Optima XR22Oamx Product Code: Class 1I, IZL, System, X-ray, Mobile, 21 CFR 892.1720 Predicate Device(s): AIVX-4 Plus Mobile X-ray system K021016 GE Definium AMX700, Model AMiX 700 K052897 WIRELESS DR IMAGING OPTION… | 2002 |
| * | K052897 | GE Definium Amx 700, Model Amx 700Summary page 1…em, X-ray, Mobile, 21 CFR 892.1720 Predicate Device(s): AIVX-4 Plus Mobile X-ray system K021016 GE Definium AMX700, Model AMiX 700 K052897 WIRELESS DR IMAGING OPTION WDR1 K10261 5 (pending)… | 2005 |
| * | K102615 | Wireless DR Imaging Option-WDR1Summary page 1…4 Plus Mobile X-ray system K021016 GE Definium AMX700, Model AMiX 700 K052897 WIRELESS DR IMAGING OPTION WDR1 K10261 5 (pending) 5-2… | 2010 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142383 | Optima XR200amx, Optima XR220amx | 2014 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 5, 2026 | Class II | Z-2727-2026 | Process control | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the… |
| Jun 5, 2026 | Class II | Z-2726-2026 | Process control | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the… |
| Nov 25, 2024 | Class II | Z-0811-2025 | Component design/selection | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the… |
| Nov 25, 2024 | Class II | Z-0812-2025 | Component design/selection | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the… |
| Dec 23, 2015 | Class II | Z-0769-2016 | Device Design | Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a… |
| Dec 19, 2014 | Class II | Z-1405-2015 | Radiation Control for Health and Safety Act | An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec. |
| Nov 7, 2013 | Class II | Z-0725-2014 | Software design | There exists a software issue associated with patient selection from the worklist on the Optima XR200 with Digital Upgrade, and Optima XR220amx Mobile X-ray Systems. Intermittently when a large number of patient exams are retrieved from… |
| Aug 7, 2012 | Class II | Z-1942-2013 | Software design | GE Healthcare conducted a recall on various mobile x-ray units (Optima XR220amx, Optima XR200amx, and Brivo XR285amx systems) because of an Erratic Drive Performance. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 7 of the 11 ancestors have a recall of any class.
- Of its descendants, K142383 (Ge Medical Systems, LLC, 2014) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K021016.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 GE Automatic Mobile X-Ray (AMX) Series: Brivo XR-28Samx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR). Brivo XR285arnx, Optima XR200amnx, Optima XR22Oamx are self-contained; battery operated…
Read the full statement (231 words)
The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR-28Samx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).
Brivo XR285arnx, Optima XR200amnx, Optima XR22Oamx are self-contained; battery operated mobile radiographic imaging systems 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 series are 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 RAID room.
The systems are 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.
These devices are not intended for mammographic applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103476 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103476: BRIVOXR285AMX, Optima XR200AMX, OPTIMAXR220AMX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103476
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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