510(k) Report

510(k) · Cleared

Cleared

Orthoceph OC100 D

K001439510(k) TraditionalCleared Jun 22, 200045-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. · MUH System, X-Ray, Extraoral Source, Digital

Cleared on Jun 22, 2000 after a 45-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 39 later devices descend from it.

Decided
Jun 22, 2000
Review
45 days
Class
Class II
Product code
MUH
Recalls
None
Predicates
0

39 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2008: 2 descendants cleared2002: 1 descendant cleared2003: 1 descendant cleared2006: 1 descendant cleared2014: 2 descendants cleared2010: 3 descendants cleared2013: 4 descendants cleared2020: 2 descendants cleared2022: 2 descendants cleared2015: 1 descendant cleared2011: 1 descendant cleared2012: 1 descendant cleared2016: 3 descendants cleared2019: 1 descendant cleared2025: 1 descendant cleared2018: 3 descendants cleared2017: 3 descendants cleared2023: 3 descendants cleared2021: 2 descendants cleared2024: 1 descendant cleared200020052010201520202025
  1. This deviceK001439 Orthoceph OC100 DInstrumentarium Corp. · 2000
  2. Descendant · cites it directly · 24 of its ownK030699 Veraviewepocs Panoramic/Cephalometric X-Ray Unit with CephalometricJ. Morita Mfg. Corp. · 2003
  3. Descendant · 2 generations on · 22 of its ownK073696 VeraviewepocsJ. Morita USA, Inc. · 2008
  4. Descendant · 3 generations on · 21 of its ownK093683 Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY · 2010
  5. Descendant · 4 generations on · 11 of its ownK111231 Panoura 18SThe Yoshida Dental Mfg. Co., Ltd. · 2011
  6. Descendant · cites it directly · 10 of its ownK043612 Orthopantomograph OP200, OP200D, and Orthoceph OC200, OC200DInstrumentarium Corp. Imaging Division · 2005

Showing 5 of 39 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12005: 12006: 12008: 22010: 32011: 12012: 12013: 42014: 22015: 12016: 32017: 32018: 32019: 12020: 22021: 22022: 22023: 32024: 12025: 1
2002high 4 (2013) · low 0 (2004)2026

Most influential descendants

Showing 5 of 39 · See all
  • K030699Veraviewepocs Panoramic/Cephalometric X-Ray Unit with CephalometricJ. Morita Mfg. Corp. · 2003 · cites it directly24descendants
  • K073696VeraviewepocsJ. Morita USA, Inc. · 2008 · 2 generations on22descendants
  • K093683Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY · 2010 · 3 generations on21descendants
  • K111231Panoura 18SThe Yoshida Dental Mfg. Co., Ltd. · 2011 · 4 generations on11descendants
  • K043612Orthopantomograph OP200, OP200D, and Orthoceph OC200, OC200DInstrumentarium Corp. Imaging Division · 2005 · cites it directly10descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001439Orthoceph OC100 DInstrumentarium Corp.2000—
+1K030699Veraviewepocs Panoramic/Cephalometric X-Ray Unit with CephalometricJ. Morita Mfg. Corp.2003—
+2K073696VeraviewepocsJ. Morita USA, Inc.2008—
+3K093683Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY2010—
+4K111231Panoura 18SThe Yoshida Dental Mfg. Co., Ltd.2011—
+1K043612Orthopantomograph OP200, OP200D, and Orthoceph OC200, OC200DInstrumentarium Corp. Imaging Division2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200510
200610
200820
201030
201110
201210
201340
201420
201510
201630
201730
201830
201910
202020
202120
202220
202330
202410
202510
FIG. 1 — Lineage of K001439, 2000–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 MUH? 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 MUH device

  1. #1 K242778 X Sensor (Model: IOS-A15IF, HDI-15DGF)score 16.0 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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? (39)

See all 39

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

NumberDeviceApplicantDecidedDescendants
K030699Veraviewepocs Panoramic/Cephalometric X-Ray Unit with CephalometricJ. Morita Mfg. Corp.200324
K043612Orthopantomograph OP200, OP200D, and Orthoceph OC200, OC200DInstrumentarium Corp. Imaging Division200510
K073365Dental Digital X-Ray Imaging SystemVATECH Co., Ltd.20081
K021372Veraviewepocs Panoramic X-Ray Unit with Cephalometric CapabilityJ. Morita USA, Inc.20020

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, K030699 (J. Morita Mfg. Corp., 2003) has gone furthest, with 24 descendants of its own.

How does its category compare?

All MUH devices

MUH System, X-Ray, Extraoral Source, Digital: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MUH

3in 2025

2007: 112008: 82009: 92010: 92011: 102012: 92013: 92014: 82015: 122016: 62017: 92018: 32019: 52020: 52021: 102022: 72023: 112024: 42025: 32026 (partial year): 2
2007high 12 (2015) · low 3 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MUH

159in 2025

2007: 48 days median2008: 64 days median2009: 88 days median2010: 174 days median2011: 89 days median2012: 81 days median2013: 172 days median2014: 168 days median2015: 111 days median2016: 47 days median2017: 84 days median2018: 29 days median2019: 64 days median2020: 36 days median2021: 80 days median2022: 57 days median2023: 57 days median2024: 144 days median2025: 159 days median
2007high 174 (2010) · low 29 (2018)2026

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

Recalls per year · MUH

1in 2015

2008: 12009: 22013: 12014: 12015: 1
2007high 2 (2009) · low 0 (2007)2026

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

Adverse event reports per year · MUH

1in 2025

2009: 122010: 92012: 52013: 12014: 52015: 32016: 12017: 42018: 102019: 62021: 12023: 12025: 1
2007high 12 (2009) · low 0 (2007)2025

MAUDE reports naming product code MUH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007114800
200886410
2009988212
2010917409
2011108900
201298105
2013917211
2014816815
20151211113
201664701
201798404
2018329010
201956406
202053600
2021108001
202275700
2023115701
2024414400
2025315901
20262—0—

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https://510kreport.com/device/K001439 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001439: Orthoceph OC100 D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001439

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