510(k) Report

510(k) · Cleared

Cleared

Computed Oral Radiology System

K933455510(k) TraditionalCleared Jan 31, 1994201-day reviewClass II21 CFR 872.1810

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

Schick Technologies, Inc. · EAP Unit, X-Ray, Intraoral

Cleared on Jan 31, 1994 after a 201-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 125 later devices descend from it.

Decided
Jan 31, 1994
Review
201 days
Class
Class II
Product code
EAP
Recalls
None
Predicates
0

125 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2007: 4 descendants cleared2009: 4 descendants cleared2004: 3 descendants cleared2002: 2 descendants cleared2000: 1 descendant cleared1999: 1 descendant cleared1997: 1 descendant cleared2006: 1 descendant cleared2017: 6 descendants cleared2013: 2 descendants cleared2011: 6 descendants cleared2008: 2 descendants cleared2022: 7 descendants cleared2015: 9 descendants cleared2014: 6 descendants cleared2012: 5 descendants cleared2020: 9 descendants cleared2021: 10 descendants cleared2019: 8 descendants cleared2016: 5 descendants cleared2026: 6 descendants cleared2023: 10 descendants cleared2024: 6 descendants cleared2018: 5 descendants cleared2025: 6 descendants cleared1990200020102020
  1. This deviceK933455 Computed Oral Radiology SystemSchick Technologies, Inc. · 1994
  2. Descendant · cites it directly · 106 of its ownK022953 Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2002
  3. Descendant · cites it directly · 61 of its ownK041385 Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2004
  4. Descendant · cites it directly · 59 of its ownK072134 Schick Computed Oral Radiology SystemSchick Technologies, Inc. · 2007
  5. Descendant · 2 generations on · 44 of its ownK070505 Krystal-X WifiOwandy · 2007
  6. Descendant · 3 generations on · 43 of its ownK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled

Showing 5 of 125 descendants. See all descendants

Descendants cleared per year

1997: 11999: 12000: 12002: 22004: 32006: 12007: 42008: 22009: 42011: 62012: 52013: 22014: 62015: 92016: 52017: 62018: 52019: 82020: 92021: 102022: 72023: 102024: 62025: 62026: 6
1997high 10 (2021) · low 0 (1998)2026

Most influential descendants

Showing 5 of 125 · See all
  • K022953Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2002 · cites it directly106descendants
  • K041385Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2004 · cites it directly61descendants
  • K072134Schick Computed Oral Radiology SystemSchick Technologies, Inc. · 2007 · cites it directly59descendants
  • K070505Krystal-X WifiOwandy · 2007 · 2 generations on44descendants
  • K081722YSIOSiemens Medical Solutions USA, Inc. · 2008 · 3 generations on43descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K933455Computed Oral Radiology SystemSchick Technologies, Inc.1994—
+1K022953Modification to Computed Oral Radiology SystemSchick Technologies, Inc.2002—
+1K041385Modification to Computed Oral Radiology SystemSchick Technologies, Inc.2004—
+1K072134Schick Computed Oral Radiology SystemSchick Technologies, Inc.2007—
+2K070505Krystal-X WifiOwandy2007—
+3K081722YSIOSiemens Medical Solutions USA, Inc.200811

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199910
200010
200220
200430
200610
200740
200820
200940
201160
201250
201320
201460
201590
201650
201760
201850
201980
202090
2021100
202270
2023100
202460
202560
202660
FIG. 1 — Lineage of K933455, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 EAP? 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? (125)

See all 125

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

NumberDeviceApplicantDecidedDescendants
K022953Modification to Computed Oral Radiology SystemSchick Technologies, Inc.2002106
K041385Modification to Computed Oral Radiology SystemSchick Technologies, Inc.200461
K072134Schick Computed Oral Radiology SystemSchick Technologies, Inc.200759
K991098Difoti SystemElectro-Optical Sciences, Inc.199910
K043068Difoti Usb 2.0 SystemElectro-Optical Sciences, Inc.20048
K971735Accudexa Bone DensitometerSchick Technologies, Inc.19971
K093453Modification to Computed Oral Radiology SystemSchick Technologies, Inc.20090
K041831Progeny Mpse Intraoral Dental X-Ray SensorProgeny, Inc.20040
K023292Apex Hri Digital Radiography SystemKrugman Technologies, Inc.20020
K992392RTLXInfimed, Inc.20000

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, K022953 (Schick Technologies, Inc., 2002) has gone furthest, with 106 descendants of its own.

How does its category compare?

All EAP devices

EAP Unit, X-Ray, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EAP

1in 2012

2008: 12009: 12011: 12012: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EAP

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

Recalls per year · EAP

3in 2012

2012: 3
2007high 3 (2012) · low 0 (2007)2026

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

Adverse event reports per year · EAP

1in 2025

2007: 62008: 182009: 22018: 52019: 32021: 12022: 22023: 122025: 1
2007high 18 (2008) · low 0 (2010)2025

MAUDE reports naming product code EAP, 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
20070—06
20081—018
20091—02
20100—00
20111—00
20121—30
20130—00
20140—00
20150—00
20160—00
20170—00
20180—05
20190—03
20200—00
20210—01
20220—02
20230—012
20240—00
20250—01
20260—0—

More from Schick Technologies, Inc.

13 FDA decisions under this applicant name. See the company

  • K110768Computed Dental RadiographySchick Technologies, Inc. · 2011
  • K093453Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2009
  • K072134Schick Computed Oral Radiology SystemSchick Technologies, Inc. · 2007
  • K053558Ceph, Model 4900Schick Technologies, Inc. · 2006
  • K041385Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2004

Recent decisions in EAP

The EAP category page

  • K113360Medical Image Processing UnitHumanray Co,Ltd · 2012
  • K102573Provu (TM) Dental X-Ray SystemAdvanced Image Science, Inc. · 2011
  • K093453Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2009
  • K080738Dentron SensorDentron Systems, LLC · 2008
  • K052422The Envision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile)Flow X-Ray Corp. · 2005

https://510kreport.com/device/K933455 · printed Nov 5, 2026

Cite this page

510(k) Report. “K933455: Computed Oral Radiology System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K933455

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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