510(k) · Cleared

Cleared

Fuji Medical Dry Imager FM-DP 2636

K962967510(k) TraditionalCleared Oct 28, 199690-day reviewClass II21 CFR 892.2040

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. · LMC Camera, Multi Format, Radiological

Cleared on Oct 28, 1996 as substantially equivalent to K945475 (Fujifilm Medical System U.S.A., Inc., 1995) after a 90-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.

Decided: Oct 28, 1996
Review: 90 days
Class: Class II
Product code: LMC
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K945475 (1995). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK945475 Fuji Medical Laser Imager FL-IM DFujifilm Medical System U.S.A., Inc. · 1995
This deviceK962967 Fuji Medical Dry Imager FM-DP 2636Fujifilm Medical System U.S.A., Inc. · 1996
Descendant · cites it directly · 1 of its ownK024188 UP-DF500 Filmstation Digital Film ImagerSony Medical Systems · 2003
Descendant · 2 generations on · 0 of its ownK083522 Sony UP-DF750 Digital Film ImagerSony Electronics, Inc. · 2009

Most influential descendants

Showing 2 of 2 · See all

K024188UP-DF500 Filmstation Digital Film ImagerSony Medical Systems · 2003 · cites it directly1descendant
K083522Sony UP-DF750 Digital Film ImagerSony Electronics, Inc. · 2009 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K945475	Fuji Medical Laser Imager FL-IM D	Fujifilm Medical System U.S.A., Inc.	1995	—
0 (this device)	K962967	Fuji Medical Dry Imager FM-DP 2636	Fujifilm Medical System U.S.A., Inc.	1996	—
+1	K024188	UP-DF500 Filmstation Digital Film Imager	Sony Medical Systems	2003	—
+2	K083522	Sony UP-DF750 Digital Film Imager	Sony Electronics, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2009	1	0

FIG. 1 — Lineage of K962967, 1995–2009Source: 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 LMC? 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

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
*	K945475	Fuji Medical Laser Imager FL-IM D Summary page 1 …i FL-IM D. FDA assigned the predicate to regulatory class II citing 21 CFR § 892.1750. FDA’s accession number for the premarket notification for the predicate device is K945475. FDA cleared the marketing of the predicate device in a letter dated March 9, 1995. Description of the Device [21 CFR 807.92(a)(…	Fujifilm Medical System U.S.A., Inc.	1995	—

Also cleared against K945475: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K024188	UP-DF500 Filmstation Digital Film Imager	Sony Medical Systems	2003	1

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 no recall.
Of its descendants, K024188 (Sony Medical Systems, 2003) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K945475.

How does its category compare?

All LMC devices

LMC Camera, Multi Format, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LMC

2in 2014

2007high 3 (2009) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LMC

80in 2009

2007high 80 (2009)2026

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

Recalls per year · LMC

1in 2008

2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · LMC

2in 2018

2007high 2 (2018) · low 0 (2007)2025

MAUDE reports naming product code LMC, 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	1	—	0	0
2008	1	—	1	0
2009	3	80	0	0
2010	0	—	0	0
2011	1	—	0	0
2012	0	—	0	0
2013	0	—	0	1
2014	2	—	0	1
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	0
2018	0	—	0	2
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

The indications for use of the Fuji Medical Dry Imagers is the production of hard copy images from 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/K962967 · printed Nov 5, 2026

Cite this page

510(k) Report. “K962967: Fuji Medical Dry Imager FM-DP 2636.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962967

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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