510(k) · Cleared

Cleared

Optima XR120

K111304510(k) SpecialCleared Jul 19, 201171-day reviewClass II21 CFR 892.1670

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ge Medical Systems, LLC · IXL Device, Spot-Film

Cleared on Jul 19, 2011 as substantially equivalent to K052897 (General Electric Medical Systems, 2005) after a 71-day review. Its family tree reaches back 1 generation to 2005.

Decided: Jul 19, 2011
Review: 71 days
Class: Class II
Product code: IXL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K052897 (2005). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK052897 GE Definium Amx 700, Model Amx 700General Electric Medical Systems · 2005 · Recalled
This deviceK111304 Optima XR120Ge Medical Systems, LLC · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K052897	GE Definium Amx 700, Model Amx 700	General Electric Medical Systems	2005	1
0 (this device)	K111304	Optima XR120	Ge Medical Systems, LLC	2011	—

FIG. 1 — Lineage of K111304, 2005–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 IXL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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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	Applicant	Decided	Recalls
*	K052897	GE Definium Amx 700, Model Amx 700 Summary page 1 …: Optima XR120 Product Code: Class II, IZL, System, X-ray, Mobile, 21 CER 892.1720 Predicate Device(s): GE Definiumn AMX700, Model AMX 700 K052897 Intended Use: The Optima XRI 2O is indicated for use in generating radiographic i…	General Electric Medical Systems	2005	1

Also cleared against K052897: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

Its one ancestor has a recall.
1 other device also cites its predicate K052897.

How does its category compare?

All IXL devices

IXL Device, Spot-Film: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · IXL

1in 2011

2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IXL

Too few IXL 510(k)s in any year since 2007 to give a median.

Recalls per year · IXL

2in 2010

2007high 2 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IXL

1in 2025

2007high 4 (2010) · low 0 (2009)2025

MAUDE reports naming product code IXL, 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	0	—	0	1
2008	0	—	1	1
2009	0	—	0	0
2010	0	—	2	4
2011	1	—	0	1
2012	0	—	0	1
2013	0	—	0	0
2014	0	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	0
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	2
2025	0	—	0	1
2026	0	—	0	—

What is it indicated for?

The Optima XR120 is indicated for use in generating radiographic images of human anatomy. It is intended for general-purpose diagnostic procedures. It is capable of generating images on film or digitally. This device is not intended for mammographic applications.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K111304 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111304: Optima XR120.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111304

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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