510(k) · Cleared

Recalled · 2003

Fuji Wavelet Compression or Ffcomp Irreversible Compression

K991257510(k) TraditionalCleared Jun 25, 199973-day reviewClass II21 CFR 892.2050Recalls 1

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

Fujifilm Medical System U.S.A., Inc. · LLZ System, Image Processing, Radiological

Cleared on Jun 25, 1999 as substantially equivalent to K972256 (Fujifilm Medical System U.S.A., Inc., 1997) after a 73-day review. Its family tree reaches back 2 generations to 1993. It has been recalled once.

Decided: Jun 25, 1999
Review: 73 days
Class: Class II
Product code: LLZ
Recalls: 1
Predicates: 1

Its longest line of descent runs back 2 generations to K931002 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK931002 Fuji Computed Radiograp HI-C654 DMS CRT Image ConsFujifilm Medical System U.S.A., Inc. · 1993
1 generation backK972256 FCR Fuji Computed Radiography DMS CRT Image Console HI-C654 (for…Fujifilm Medical System U.S.A., Inc. · 1997
This deviceK991257 Fuji Wavelet Compression or Ffcomp Irreversible CompressionFujifilm Medical System U.S.A., Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K931002	Fuji Computed Radiograp HI-C654 DMS CRT Image Cons	Fujifilm Medical System U.S.A., Inc.	1993	—
−1	K972256	FCR Fuji Computed Radiography DMS CRT Image Console HI-C654 (for Networks)	Fujifilm Medical System U.S.A., Inc.	1997	—
0 (this device)	K991257	Fuji Wavelet Compression or Ffcomp Irreversible Compression	Fujifilm Medical System U.S.A., Inc.	1999	—

FIG. 1 — Lineage of K991257, 1993–1999Source: 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

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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
*	K972256	FCR Fuji Computed Radiography DMS CRT Image Console HI-C654 (for Networks) Summary page 1 …ltimodality display system for networks with FDA product code LLZ as unclassified (before medical device communication devices were put into class I) under 510(k) number K972256. Fuji received notification that FDA cleared the marketing of the predicate device in a letter dated September 12, 1997. Fuji is…	Fujifilm Medical System U.S.A., Inc.	1997	—
†	K982146	Pictools Medical Tool Kit Model 1.0	Pegasus Imaging Corp.	1998	—
†	K972380	Kodak Digital Science (KDS) Medical Image and Information Library (Miil)	Eastman Kodak Company	1997	—

Also cleared against K972256: 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)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 12, 2003	Not classified	Z-0932-03	Other	Synapse Version 2.2.1 and 2.3.1 Software [Free-Hand Region] may lead to incorrect density calculations during CT scan

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 4.3 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K972256.

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?

Fuji wavelet compression is intended to be used in applications to

compress digital medical image data.

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/K991257 · printed Nov 4, 2026

Cite this page

510(k) Report. “K991257: Fuji Wavelet Compression or Ffcomp Irreversible Compression.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991257

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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