510(k) · Cleared

Cleared

Film Processor, Model Life Ray Pro 1000

K023801510(k) AbbreviatedCleared Feb 12, 200390-day reviewClass II21 CFR 892.1900

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

S.a.I.E.P. S.R.L. · IXW Processor, Radiographic-Film, Automatic

Cleared on Feb 12, 2003 as substantially equivalent to K992818 (Protec GmbH & Co. KG, 1999) after a 90-day review. Its family tree reaches back 2 generations to 1995.

Decided: Feb 12, 2003
Review: 90 days
Class: Class II
Product code: IXW
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K954345 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK954345 Doosan DSP 3800 Automatic X-Ray Film ProcessorDoosan Corp. · 1995
1 generation backK992818 Optimax/ Compact 2Protec GmbH & Co. KG · 1999
This deviceK023801 Film Processor, Model Life Ray Pro 1000S.a.I.E.P. S.R.L. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K954345	Doosan DSP 3800 Automatic X-Ray Film Processor	Doosan Corp.	1995	—
−1	K992818	Optimax/ Compact 2	Protec GmbH & Co. KG	1999	—
0 (this device)	K023801	Film Processor, Model Life Ray Pro 1000	S.a.I.E.P. S.R.L.	2003	—

FIG. 1 — Lineage of K023801, 1995–2003Source: 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 IXW? 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
*	K992818	Optimax/ Compact 2 Summary page 1 …92.1900 Product Code: IXW Predicate Device Protec Medizintecnick OPTIMAX K9928 18 Additional Substantial Equivalence Information is provided in the following Substantial Equivalence Comparison Table…	Protec GmbH & Co. KG	1999	—

Also cleared against K992818: 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?

The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K992818.

How does its category compare?

All IXW devices

IXW Processor, Radiographic-Film, Automatic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IXW

1in 2011

2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IXW

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

Recalls per year · IXW

No recall names IXW since 2007.

Adverse event reports per year · IXW

2in 2018

2007high 2 (2009) · low 0 (2007)2025

MAUDE reports naming product code IXW, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	1
2009	1	—	2
2010	1	—	0
2011	1	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	2
2015	0	—	2
2016	0	—	1
2017	0	—	1
2018	0	—	2
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The Automatic Radiographic Film Processed intended to be used to process films exposed for medical purposes. The automatic and continuous process contains developing, fixing, washing and drying of films. This may be used in all general radiographic, diamostic imaging procedures. Typical users of this system are trained medical professionals, including but not limited to physicians, nurses, and lab technicians.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023801 · printed Nov 5, 2026

Cite this page

510(k) Report. “K023801: Film Processor, Model Life Ray Pro 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023801

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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