510(k) · Cleared

Cleared

Sony UP-DF750 Digital Film Imager

K083522510(k) TraditionalCleared Jan 9, 200944-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

Sony Electronics, Inc. · LMC Camera, Multi Format, Radiological

Cleared on Jan 9, 2009 as substantially equivalent to K072680 (Agfa Healthcare Corporation, 2007) and 5 other predicates after a 44-day review. Its family tree reaches back 4 generations to 2000.

Decided: Jan 9, 2009
Review: 44 days
Class: Class II
Product code: LMC
Recalls: None
Predicates: 6

Its longest line of descent runs back 4 generations to K002146 (2000). 15 ancestors in all, the oldest K945475 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK002146 Kodak Dryview 8610 Laser Imager / for MammographyEastman Kodak Company · 2000
3 generations backK012941 Drystar, Model 4500MAgfa Corp. · 2001
2 generations backK021054 Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon…Codonics, Inc. · 2002
1 generation backK024188 UP-DF500 Filmstation Digital Film ImagerSony Medical Systems · 2003
This deviceK083522 Sony UP-DF750 Digital Film ImagerSony Electronics, Inc. · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K002146	Kodak Dryview 8610 Laser Imager / for Mammography	Eastman Kodak Company	2000	—
−3	K012941	Drystar, Model 4500M	Agfa Corp.	2001	—
−2	K021054	Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon GS Medical…	Codonics, Inc.	2002	—
−1	K024188	UP-DF500 Filmstation Digital Film Imager	Sony Medical Systems	2003	—
0 (this device)	K083522	Sony UP-DF750 Digital Film Imager	Sony Electronics, Inc.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1996	1	0
1997	1	0
2001	3	0
2002	1	0
2004	3	0
2007	1	0

FIG. 1 — Lineage of K083522, 2000–2009Source: 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

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What was it cleared against? (6)

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
*	K072680	Drystar Axys, Model EYZ4E Summary page 1 …/Usual Name: Thermal Printer/Imager Classification Name: Medical Image Hardcopy Device 3. PREDICATE DEVICES · Agfa Healthcare Corporation, Drystar AXYS, K072680 * Agfa Healthcare Corporation, Drystar 4500M, K012941 . FUJIFILM Medical Systems, USA, Inc., Fuji Medical Dry Las…	Agfa Healthcare Corporation	2007	1
*	K012941	Drystar, Model 4500M Summary page 1 …Medical Image Hardcopy Device 3. PREDICATE DEVICES · Agfa Healthcare Corporation, Drystar AXYS, K072680 * Agfa Healthcare Corporation, Drystar 4500M, K012941 . FUJIFILM Medical Systems, USA, Inc., Fuji Medical Dry Laser Imager, Model DRYPIX 7000, K033377 · East…	Agfa Corp.	2001	—
*	K033377	Fuji Medical Dry Laser Imagers, Models Drypix 7000, Drypix 5000 and FM-DP L Summary page 1 …* Agfa Healthcare Corporation, Drystar 4500M, K012941 . FUJIFILM Medical Systems, USA, Inc., Fuji Medical Dry Laser Imager, Model DRYPIX 7000, K033377 · Eastman Kodak Company, KODAK DRYVIEW 8900 Laser Imager with Mammography Accessory, K033821 Konica M…	Fujifilm Medical System U.S.A., Inc.	2004	—
*	K033821	Kodak Dryview 8900 Laser Imager Mammography Accessory Summary page 1 …uji Medical Dry Laser Imager, Model DRYPIX 7000, K033377 · Eastman Kodak Company, KODAK DRYVIEW 8900 Laser Imager with Mammography Accessory, K033821 Konica Minolta Medical & Graphic Inc., Dry Laser Imager, DRYPRO Model 793, K042133 Sony Medical Sys…	Eastman Kodak Company	2004	—
*	K042133	Dry Laser Imager, Model Drypro Model 793 Summary page 1 …AK DRYVIEW 8900 Laser Imager with Mammography Accessory, K033821 Konica Minolta Medical & Graphic Inc., Dry Laser Imager, DRYPRO Model 793, K042133 Sony Medical Systems Division, UP-DF500 FilmStation Digital Film Imager, K024188 Sony Electronics Inc., T…	Konica Minolta Medical & Graphic, Inc.	2004	—
*	K024188	UP-DF500 Filmstation Digital Film Imager Summary page 1 …edical & Graphic Inc., Dry Laser Imager, DRYPRO Model 793, K042133 Sony Medical Systems Division, UP-DF500 FilmStation Digital Film Imager, K024188 Sony Electronics Inc., Traditional 510(k) November 24, 2008 Sony UP-DF750 Digital Film Imager…	Sony Medical Systems	2003	—

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 9 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
2 of the 15 ancestors have a recall of any class.

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. 2009, this device’s year, is highlighted.

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 Sony UP-DF750 Digital Film Imager is a thermal printer intended for use in printing

medical diagnostic images from mammography systems. The UP-DF750 is a multi-format

imager and also is intended for printing high-resolution diagnostic images from CT, MRI,

CR, DR and other compatible medical imaging systems. The Sony UP-DF750 is intended

for use by medical radiologists or other appropriately trained medical personnel.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K083522 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083522: Sony UP-DF750 Digital Film Imager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083522

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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