510(k) · Cleared

Cleared

Orthopantomograph OP200, OP200D, and Orthoceph OC200, OC200D

K043612510(k) TraditionalCleared Feb 9, 200541-day reviewClass II21 CFR 872.1800

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

Instrumentarium Corp. Imaging Division · EHD Unit, X-Ray, Extraoral With Timer

Cleared on Feb 9, 2005 as substantially equivalent to K992385 (Instrumentarium Corp., 1999) and 2 other predicates after a 41-day review. Its family tree reaches back 1 generation to 1997. 10 later devices descend from it.

Decided: Feb 9, 2005
Review: 41 days
Class: Class II
Product code: EHD
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K973642 (1997). 3 ancestors in all. 10 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
This deviceK043612 Orthopantomograph OP200, OP200D, and Orthoceph OC200, OC200DInstrumentarium Corp. Imaging Division · 2005
Descendant · cites it directly · 6 of its ownK141700 Papaya Plus, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd. · 2014
Descendant · 2 generations on · 4 of its ownK150354 PAPAYA 3D PlusGenoray Co., Ltd. · 2015
Descendant · 3 generations on · 1 of its ownK200469 PAPAYA 3D Premium & PAPAYA 3D Premium PlusGenoray Co., Ltd. · 2020
Descendant · cites it directly · 1 of its ownK122643 Vantage Model V5000, V5100, V5000C, V5100CMidmark Corp. · 2013 · Recalled
Descendant · 4 generations on · 0 of its ownK250060 GT300; GT300-CGenoray Co., Ltd. · 2025

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2010high 2 (2020) · low 0 (2011)2026

Most influential descendants

Showing 5 of 10 · See all

K141700Papaya Plus, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd. · 2014 · cites it directly6descendants
K150354PAPAYA 3D PlusGenoray Co., Ltd. · 2015 · 2 generations on4descendants
K200469PAPAYA 3D Premium & PAPAYA 3D Premium PlusGenoray Co., Ltd. · 2020 · 3 generations on1descendant
K122643Vantage Model V5000, V5100, V5000C, V5100CMidmark Corp. · 2013 · cites it directly1descendant
K250060GT300; GT300-CGenoray Co., Ltd. · 2025 · 4 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K973642	Orthopantomograph OP100 and Orthoceph OC100	Instrumentarium Imaging, Inc.	1997	—
0 (this device)	K043612	Orthopantomograph OP200, OP200D, and Orthoceph OC200, OC200D	Instrumentarium Corp. Imaging Division	2005	—
+1	K141700	Papaya Plus, Digital Extraoral Source X-Ray System	Genoray Co., Ltd.	2014	—
+2	K150354	PAPAYA 3D Plus	Genoray Co., Ltd.	2015	—
+3	K200469	PAPAYA 3D Premium & PAPAYA 3D Premium Plus	Genoray Co., Ltd.	2020	—
+1	K122643	Vantage Model V5000, V5100, V5000C, V5100C	Midmark Corp.	2013	2
+4	K250060	GT300; GT300-C	Genoray Co., Ltd.	2025	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2013	1	0
2014	1	0
2015	1	0
2016	1	0
2020	2	0
2022	2	0
2025	1	0

FIG. 1 — Lineage of K043612, 1997–2025Source: 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 EHD? 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 EHD device

#1 K260795 Hand-held Dental X-ray System (HyperLight-M)score 14.1 · 8 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? (3)

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
*	K992385	Orthopantomograph OP100D Summary page 2 …devices introduced into commercial distribution after May 28, 1976: Orthopantomograph®OP100D #K992385 Orthoceph®OC100D #K001439 Orthopanto…	Instrumentarium Corp.	1999	—
*	K001439	Orthoceph OC100 D Summary page 2 …Orthopantomograph®OP100D #K992385 Orthoceph®OC100D #K001439 Orthopantomograph® OP100 and Orthoceph® OC1OO…	Instrumentarium Corp.	2000	—
*	K973642	Orthopantomograph OP100 and Orthoceph OC100 Summary page 2 …#K001439 Orthopantomograph® OP100 and Orthoceph® OC1OO #K973642 General Electric Company Instrumentarium Corp. Imaging Division Nahkelantie 160, P.O.Box 20 T+358 10 394 6500 FIN-043…	Instrumentarium Imaging, Inc.	1997	—

Also cleared against K992385: 2 other devices →

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K141700	Papaya Plus, Digital Extraoral Source X-Ray System	Genoray Co., Ltd.	2014	6
K122643	Vantage Model V5000, V5100, V5000C, V5100C	Midmark Corp.	2013	1
K101661	Myray Hyperion	Cefla Dental Group	2010	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?

None of the 3 ancestors has a recall.
Of its descendants, K141700 (Genoray Co., Ltd., 2014) has gone furthest, with 6 descendants of its own.
2 other devices also cite its predicate K992385.

How does its category compare?

All EHD devices

EHD Unit, X-Ray, Extraoral With Timer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EHD

1in 2025

2007high 8 (2022) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EHD

58in 2024

2007high 268 (2010) · low 28 (2017)2026

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

Recalls per year · EHD

1in 2017

2007high 3 (2010) · low 0 (2007)2026

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

Adverse event reports per year · EHD

6in 2024

2007high 110 (2015) · low 0 (2025)2025

MAUDE reports naming product code EHD, 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	5
2008	5	49	0	6
2009	4	92	0	38
2010	4	268	3	47
2011	3	102	3	26
2012	2	—	0	22
2013	4	216	0	21
2014	3	107	1	20
2015	1	—	0	110
2016	2	—	1	63
2017	4	28	1	66
2018	5	30	0	21
2019	4	173	0	21
2020	2	—	0	4
2021	1	—	0	4
2022	8	58	0	4
2023	8	147	0	2
2024	7	58	0	6
2025	1	—	0	0
2026	6	128	0	—

What is it indicated for?

Orthopantomograph® OP200 (film unit) and OP200 D (digital unit) devices are intended to be used for producing X-ray radiographs of dentition, TM-joints and other oral structures. The units are capable of taking panoramic, TM-joint and maxillary sinus radiographs from patients. When the units are equipped with cephalometric option Orthoceph® OC200 (film unit) or OC200 D (digital unit) units can be used for cephalometric radiography and examinations related thereto. OP200 or OC200 units can also be equipped with Ortho Trans (OT) option, which is capable of taking both cross and longitudinal slices of region of interest. Ortho Trans uses linear tomography imaging principle.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K043612 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043612: Orthopantomograph OP200, OP200D, and Orthoceph OC200, OC200D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043612

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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