510(k) · Cleared

Cleared

Kodak Radiation Oncology Software/ for Acr Systems

K012155510(k) SpecialCleared Aug 10, 200130-day reviewClass II21 CFR 892.2050

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

Eastman Kodak Company · LLZ System, Image Processing, Radiological

Cleared on Aug 10, 2001 as substantially equivalent to K980213 (Lumisys, Inc., 1998) after a 30-day review. Its family tree reaches back 3 generations to 1995.

Decided: Aug 10, 2001
Review: 30 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K952914 (1995). 6 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK952914 Star Technologies, Inc. Film Image Scan SystemStar Technologies, Inc. · 1995
2 generations backK972191 Digitizer Director (HSC025-01)Howtek, Inc. · 1997
1 generation backK980213 DI-2000Lumisys, Inc. · 1998
This deviceK012155 Kodak Radiation Oncology Software/ for Acr SystemsEastman Kodak Company · 2001

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K952914	Star Technologies, Inc. Film Image Scan System	Star Technologies, Inc.	1995	—
−2	K972191	Digitizer Director (HSC025-01)	Howtek, Inc.	1997	—
−1	K980213	DI-2000	Lumisys, Inc.	1998	—
0 (this device)	K012155	Kodak Radiation Oncology Software/ for Acr Systems	Eastman Kodak Company	2001	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	2	0
1997	1	0

FIG. 1 — Lineage of K012155, 1995–2001Source: 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 LLZ? 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 LLZ device

#1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) 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	Applicant	Decided	Recalls
*	K980213	DI-2000 Summary page 1 …ommon Name: DICOM Client Classification Name: PACS under 21 CFR 892.2050 The Kodak Radiation Oncology Software is substantially equivalent to the DI- 2000 DICOM Client (K980213, March 17, 1998), formerly owned by Lumisys, Inc. Continued on next page Eastman Kodak Company Kodak Radiation Oncology Softwar…	Lumisys, Inc.	1998	—

Also cleared against K980213: 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 6 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
None of the 6 ancestors has a recall.
1 other device also cites its predicate K980213.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007high 64 (2013) · low 2 (2019)2026

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

Adverse event reports per year · LLZ

116in 2025

2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, 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	76	36	20	152
2008	94	52	32	154
2009	70	62	21	145
2010	51	98	17	145
2011	106	79	30	454
2012	82	87	12	266
2013	95	84	64	1,130
2014	78	89	6	15,631
2015	64	90	16	211
2016	82	90	12	290
2017	78	107	5	104
2018	104	105	7	72
2019	74	107	2	88
2020	81	115	6	82
2021	83	116	3	70
2022	65	137	4	28
2023	87	157	8	26
2024	62	131	6	42
2025	58	173	11	116
2026	45	110	14	—

What is it indicated for?

Kodak Radiation Oncology Software / for ACR systems is intended to utilize a scanner and software interface to digitize computed radiography exposed phosphor plates.

Kodak Radiation Oncology Software / for ACR systems is DICOM 3.0 compliant radiological digitization application.

Kodak Radiation Oncology Software / for ACR systems is enables, the user to autoarchive lossless or lossy compressed images locally or at a remote archive site. Supports DICOM 3.0 Query and Retrieve Service Class.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012155 · printed Nov 3, 2026

Cite this page

510(k) Report. “K012155: Kodak Radiation Oncology Software/ for Acr Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K012155

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026