510(k) · Cleared

Cleared

Fujifilm Unity Speedsuite, Model CR-IR 371

K073650510(k) TraditionalCleared Feb 6, 200842-day reviewClass II21 CFR 892.1680

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

Fujifilm Medical Systems U.S.A, Inc. · KPR System, X-Ray, Stationary

Cleared on Feb 6, 2008 as substantially equivalent to K012546 (Sedecal USA, Inc., 2001) and 3 other predicates after a 42-day review. Its family tree reaches back 5 generations to 1998.

Decided: Feb 6, 2008
Review: 42 days
Class: Class II
Product code: KPR
Recalls: None
Predicates: 4

Its longest line of descent runs back 5 generations to K981556 (1998). 11 ancestors in all, the oldest K951373 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
4 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
3 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
2 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
1 generation backK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
This deviceK073650 Fujifilm Unity Speedsuite, Model CR-IR 371Fujifilm Medical Systems U.S.A, Inc. · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K981556	Canon X-Ray Digital Camera Cxdi-11	Canon USA, Inc.	1998	—
−4	K992547	Canon X-Ray Digital Camera, Model Cxdi-22	Canon USA, Inc.	1999	—
−3	K023750	Cannon Digital Radiography Model Cxdi-40G	Canon USA, Inc.	2002	—
−2	K031447	Canon, Digital Radiography, Model Cxdi-50G	Canon, Inc.	2003	—
−1	K042876	Urs LP Digital, Millennium, Radpro	Sedecal., Sa.	2004	—
0 (this device)	K073650	Fujifilm Unity Speedsuite, Model CR-IR 371	Fujifilm Medical Systems U.S.A, Inc.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
2000	1	0
2001	1	0
2002	1	0
2003	1	0
2004	1	0

FIG. 1 — Lineage of K073650, 1998–2008Source: 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 KPR? 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 KPR device

#1 K242119 Innovision-Exiiscore 17.0 · 9 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? (4)

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
*	K012546	Optima Urs Universal Radiographic System Summary page 1 …legally marketed devices: This notification is for a MODIFIED device. This device COMBINES three 510(k) cleared devices, the SEDECAL Universal Radiographic Systems K012546, the detector used in the Fujifilm Fuji Computed Radiography (FCR) Velocity Image Reader K033561, and the Fuji Medical CR/DR C…	Sedecal USA, Inc.	2001	2
*	K033561	Fuji Computed Radiography (FCR) Velocity Image Reader Summary page 1 …510(k) cleared devices, the SEDECAL Universal Radiographic Systems K012546, the detector used in the Fujifilm Fuji Computed Radiography (FCR) Velocity Image Reader K033561, and the Fuji Medical CR/DR Console, Flash LIP. This combination is functionally identical to a SEDECAL cleared device, Sedeca…	Fujifilm Medical System U.S.A., Inc.	2003	—
*	K041990	Fuji Medical CR Console, Model Flash Iip Summary page 2 …bines three (Predicate Device) cleared devices: Fuji K033561/K041990 AND Sedecal…	Fujifilm Medical System U.S.A., Inc.	2004	—
*	K042876	Urs LP Digital, Millennium, Radpro Summary page 1 …he Fuji Medical CR/DR Console, Flash LIP. This combination is functionally identical to a SEDECAL cleared device, Sedecal URS LP X-Ray Units with Digital Detector, K042876. 3. Indications for Use (intended use): Intended for use by a qualified/trained doctor or technician on both adult and pediat…	Sedecal., Sa.	2004	—

Also cleared against K012546: 6 other devices →

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 10 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
1 of the 11 ancestors has a recall of any class.
6 other devices also cite its predicate K012546.

How does its category compare?

All KPR devices

KPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · KPR

8in 2025

2007high 18 (2015) · low 5 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPR

155in 2025

2007high 197 (2026) · low 30 (2018)2026

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

Recalls per year · KPR

7in 2025

2007high 10 (2007) · low 0 (2021)2026

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

Adverse event reports per year · KPR

39in 2025

2007high 120 (2007) · low 18 (2016)2025

MAUDE reports naming product code KPR, 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	12	31	10	120
2008	15	48	10	95
2009	9	35	5	61
2010	9	126	3	82
2011	9	152	5	103
2012	11	58	1	74
2013	5	163	5	24
2014	10	108	8	34
2015	18	81	1	59
2016	11	84	4	18
2017	6	75	3	31
2018	15	30	4	36
2019	12	33	1	77
2020	16	39	1	41
2021	6	55	0	37
2022	8	43	2	27
2023	9	76	4	39
2024	11	162	1	34
2025	8	155	7	39
2026	6	197	0	—

What is it indicated for?

FUJIFILM Unity SpeedSuite X-Ray System is Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K073650 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073650: Fujifilm Unity Speedsuite, Model CR-IR 371.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073650

Report an extraction error

Are you the manufacturer?

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