510(k) · Cleared

Cleared

Regius Model 170 Direct Digitizer

K051998510(k) TraditionalCleared Nov 3, 2005101-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

Konica Minolta Medical & Graphic, Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

Cleared on Nov 3, 2005 as substantially equivalent to K023061 (Konica Minolta Medical & Graphic, Inc., 2002) after a 101-day review. Its family tree reaches back 1 generation to 2002. 1 later device descends from it.

Decided: Nov 3, 2005
Review: 101 days
Class: Class II
Product code: MQB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K023061 (2002). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK023061 Konica Direct Digitizer Regius, Model 170Konica Minolta Medical & Graphic, Inc. · 2002
This deviceK051998 Regius Model 170 Direct DigitizerKonica Minolta Medical & Graphic, Inc. · 2005
Descendant · cites it directly · 0 of its ownK120752 Aerodr Stitching SystemKonica Minolta Medical & Graphic, Inc. · 2012

Most influential descendants

Showing 1 of 1 · See all

K120752Aerodr Stitching SystemKonica Minolta Medical & Graphic, Inc. · 2012 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K023061	Konica Direct Digitizer Regius, Model 170	Konica Minolta Medical & Graphic, Inc.	2002	—
0 (this device)	K051998	Regius Model 170 Direct Digitizer	Konica Minolta Medical & Graphic, Inc.	2005	—
+1	K120752	Aerodr Stitching System	Konica Minolta Medical & Graphic, Inc.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0

FIG. 1 — Lineage of K051998, 2002–2012Source: 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 MQB? 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 MQB device

#1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 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
*	K023061	Konica Direct Digitizer Regius, Model 170 Summary page 1 …21 CFR 892. 1650. 7. Predicate Device Modified Direct Digitizer REGIUS MODEL 170 is substantially equivalent to our current Direct Digitizer, MODEL 170, 510(k) number: K023061. 8. Description of Device The Direct Digitizer, REGIUS MODEL 170 is an X-ray image reader which uses a stimulabl…	Konica Minolta Medical & Graphic, Inc.	2002	—

Also cleared against K023061: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K120752	Aerodr Stitching System	Konica Minolta Medical & Graphic, Inc.	2012	0

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, K120752 (Konica Minolta Medical & Graphic, Inc., 2012) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K023061.

How does its category compare?

All MQB devices

MQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQB

8in 2025

2007high 32 (2014) · low 8 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQB

127in 2025

2007high 245 (2026) · low 15 (2008)2026

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

Recalls per year · MQB

1in 2025

2007high 36 (2008) · low 0 (2014)2026

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

Adverse event reports per year · MQB

141in 2025

2007high 267 (2012) · low 9 (2020)2025

MAUDE reports naming product code MQB, 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	13	22	15	25
2008	8	15	36	30
2009	15	57	19	34
2010	11	116	14	39
2011	24	102	10	101
2012	22	80	8	267
2013	21	105	6	159
2014	32	102	0	29
2015	21	81	0	21
2016	22	92	0	26
2017	31	30	1	20
2018	16	30	4	84
2019	22	30	1	45
2020	19	28	4	9
2021	21	48	1	26
2022	31	48	0	13
2023	10	30	0	51
2024	8	187	0	91
2025	8	127	1	141
2026	3	245	1	—

What is it indicated for?

The Direct Digitizer, REGIUS MODEL 170 is an X-ray image reader which uses a stimulable phosphor plate (Plate) as X-ray detector installed in a separate cassette. It reads the image recorded on the Plate and transfers the image data to an externally connected device such as a host computer, an order input device, an image display device, a printer, an image data filing device, and other image reproduction devices. REGIUS MODEL 170 is used to obtain image…

Read the full statement (140 words)

The Direct Digitizer, REGIUS MODEL 170 is an X-ray image reader which uses a

stimulable phosphor plate (Plate) as X-ray detector installed in a separate cassette. It

reads the image recorded on the Plate and transfers the image data to an externally

connected device such as a host computer, an order input device, an image display

device, a printer, an image data filing device, and other image reproduction devices.

REGIUS MODEL 170 is used to obtain image data of long areas of anatomy such as the

whole spine or the whole lower leg.

REGIUS MODEL 170 is also used to obtain image data to verify the position for a

radiotherapy location.

It is designed intended to use in a clinic, a radiology department in a hospital and in other

medical facilities.

Itis not intended for use with digital mammography system.

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/K051998 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051998: Regius Model 170 Direct Digitizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051998

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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