510(k) · Cleared

Cleared

Digora

K934949510(k) TraditionalCleared Feb 10, 1994115-day reviewClass II21 CFR 892.1630

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

Orion Corporation Soredex · IXK System, Imaging, X-Ray, Electrostatic

Cleared on Feb 10, 1994 after a 115-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 21 later devices descend from it.

Decided: Feb 10, 1994
Review: 115 days
Class: Class II
Product code: IXK
Recalls: None
Predicates: 0

21 later devices descend from it, 5 citing it directly.

This deviceK934949 DigoraOrion Corporation Soredex · 1994
Descendant · cites it directly · 14 of its ownK041050 Digora Optime (or Digora Ontime)Soredex Palodex Group OY · 2004 · Recalled
Descendant · 2 generations on · 9 of its ownK133231 Digora OptimeInstrumentarium Dental, Palodex Group OY · 2014
Descendant · 2 generations on · 9 of its ownK131442 Firecr Dentalimaging System3Disc Americas · 2013
Descendant · 3 generations on · 6 of its ownK160788 RIOScan (RPS500)Ray Co., Ltd. · 2016
Descendant · 4 generations on · 5 of its ownK170733 ScanX Intraoral ViewDuerr Dental AG · 2017

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

1996high 3 (2023) · low 0 (1997)2026

Most influential descendants

Showing 5 of 21 · See all

K041050Digora Optime (or Digora Ontime)Soredex Palodex Group OY · 2004 · cites it directly14descendants
K133231Digora OptimeInstrumentarium Dental, Palodex Group OY · 2014 · 2 generations on9descendants
K131442Firecr Dentalimaging System3Disc Americas · 2013 · 2 generations on9descendants
K160788RIOScan (RPS500)Ray Co., Ltd. · 2016 · 3 generations on6descendants
K170733ScanX Intraoral ViewDuerr Dental AG · 2017 · 4 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K934949	Digora	Orion Corporation Soredex	1994	—
+1	K041050	Digora Optime (or Digora Ontime)	Soredex Palodex Group OY	2004	4
+2	K133231	Digora Optime	Instrumentarium Dental, Palodex Group OY	2014	—
+2	K131442	Firecr Dentalimaging System	3Disc Americas	2013	—
+3	K160788	RIOScan (RPS500)	Ray Co., Ltd.	2016	—
+4	K170733	ScanX Intraoral View	Duerr Dental AG	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1998	1	0
1999	1	0
2001	1	0
2004	1	0
2007	1	0
2011	2	0
2013	1	0
2014	1	0
2015	1	0
2016	2	0
2017	1	0
2019	2	0
2020	1	0
2021	1	0
2023	3	0

FIG. 1 — Lineage of K934949, 1994–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IXK? 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (21)

See all 21

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K041050	Digora Optime (or Digora Ontime)	Soredex Palodex Group OY	2004	14
K955643	Alara Imaging System	Denoptix, Inc.	1996	4
K974619	Scanaray/CD-Dent Advanced Computerized X-Ray System	Afp Imaging Corp.	1998	1
K012170	Digora PCT	Soredex Palodex Group OY	2001	0
K990049	CD-Dent Digital Imaging Devices for Dental X-Ray Systems, Models 600, 1000 and 2000	Digident, Ltd.	1999	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?

Of its descendants, K041050 (Soredex Palodex Group OY, 2004) has gone furthest, with 14 descendants of its own.

How does its category compare?

All IXK devices

IXK System, Imaging, X-Ray, Electrostatic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IXK

1in 2011

2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IXK

Too few IXK 510(k)s in any year since 2007 to give a median.

Recalls per year · IXK

No recall names IXK since 2007.

Adverse event reports per year · IXK

No MAUDE report names IXK since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	1	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

https://510kreport.com/device/K934949 · printed Nov 6, 2026

Cite this page

510(k) Report. “K934949: Digora.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934949

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026