510(k) · Cleared

Cleared

Modification to Computed Oral Radiology System

K041385510(k) SpecialCleared Jun 7, 200413-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 Jun 7, 2004 as substantially equivalent to K933455 (Schick Technologies, Inc., 1994) after a 13-day review. Its family tree reaches back 1 generation to 1994. 61 later devices descend from it.

Decided: Jun 7, 2004
Review: 13 days
Class: Class II
Product code: EAP
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K933455 (1994). 61 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK933455 Computed Oral Radiology SystemSchick Technologies, Inc. · 1994
This deviceK041385 Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2004
Descendant · cites it directly · 59 of its ownK072134 Schick Computed Oral Radiology SystemSchick Technologies, Inc. · 2007
Descendant · 2 generations on · 18 of its ownK090526 Medical Image Processing Unit, Model EzsensorE-Woo Technology · 2009
Descendant · 2 generations on · 18 of its ownK090458 Dexis SensorDexis, LLC · 2009
Descendant · 2 generations on · 13 of its ownK103290 Edlen Imaging - Gemini DusbEdlen Imaging, LLC · 2011
Descendant · 2 generations on · 11 of its ownK150823 EDLENi Intra-Oral SensorEdlen Imaging, LLC · 2015

Showing 5 of 61 descendants. See all descendants

Descendants cleared per year

2006high 7 (2015) · low 0 (2010)2026

Most influential descendants

Showing 5 of 61 · See all

K072134Schick Computed Oral Radiology SystemSchick Technologies, Inc. · 2007 · cites it directly59descendants
K090526Medical Image Processing Unit, Model EzsensorE-Woo Technology · 2009 · 2 generations on18descendants
K090458Dexis SensorDexis, LLC · 2009 · 2 generations on18descendants
K103290Edlen Imaging - Gemini DusbEdlen Imaging, LLC · 2011 · 2 generations on13descendants
K150823EDLENi Intra-Oral SensorEdlen Imaging, LLC · 2015 · 2 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K933455	Computed Oral Radiology System	Schick Technologies, Inc.	1994	—
0 (this device)	K041385	Modification to Computed Oral Radiology System	Schick Technologies, Inc.	2004	—
+1	K072134	Schick Computed Oral Radiology System	Schick Technologies, Inc.	2007	—
+2	K090526	Medical Image Processing Unit, Model Ezsensor	E-Woo Technology	2009	—
+2	K090458	Dexis Sensor	Dexis, LLC	2009	—
+2	K103290	Edlen Imaging - Gemini Dusb	Edlen Imaging, LLC	2011	—
+2	K150823	EDLENi Intra-Oral Sensor	Edlen Imaging, LLC	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0
2008	1	0
2009	4	0
2011	5	0
2012	3	0
2013	1	0
2014	3	0
2015	7	0
2016	2	0
2017	4	0
2018	2	0
2019	1	0
2020	4	0
2021	7	0
2022	3	0
2023	6	0
2024	3	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K041385, 1994–2026Source: 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 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? (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
*	K933455	Computed Oral Radiology System Summary page 1 …aniel Michaeli, Prepared: May 24, 2004 A. Legally Marketed Predicate Devices The original Computed Oral Radiology System notification was cleared on January 31%, 1994 (K933455). The device and its predicate are small digital imaging receptors that may be used in place of dental x-ray film. B. Modificati…	Schick Technologies, Inc.	1994	—

Also cleared against K933455: 9 other devices →

What descends from it? (61)

See all 61

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

Number	Device	Applicant	Decided	Descendants
K072134	Schick Computed Oral Radiology System	Schick Technologies, Inc.	2007	59
K093453	Modification to Computed Oral Radiology System	Schick Technologies, Inc.	2009	0
K053558	Ceph, Model 4900	Schick Technologies, Inc.	2006	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, K072134 (Schick Technologies, Inc., 2007) has gone furthest, with 59 descendants of its own.
9 other devices also cite its predicate K933455.

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

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

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	6
2008	1	—	0	18
2009	1	—	0	2
2010	0	—	0	0
2011	1	—	0	0
2012	1	—	3	0
2013	0	—	0	0
2014	0	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	0
2018	0	—	0	5
2019	0	—	0	3
2020	0	—	0	0
2021	0	—	0	1
2022	0	—	0	2
2023	0	—	0	12
2024	0	—	0	0
2025	0	—	0	1
2026	0	—	0	—

What is it indicated for?

The Computed Oral Radiology System is indicated for patients undergoing an intra-oral dental x-ray examination. It produces instant, digital, intra-oral x-ray images of a patient’s mouth while reducing the necessary x-ray dosage.

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/K041385 · printed Nov 4, 2026

Cite this page

510(k) Report. “K041385: Modification to Computed Oral Radiology System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041385

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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