510(k) · Cleared
ClearedSchick Computed Oral Radiology System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schick Technologies, Inc. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Nov 2, 2007 as substantially equivalent to K041385 (Schick Technologies, Inc., 2004) and 2 other predicates after a 92-day review. Its family tree reaches back 2 generations to 1994. 59 later devices descend from it.
- Decided
- Nov 2, 2007
- Review
- 92 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K933455 (1994). 3 ancestors in all. 59 later devices descend from it, 12 citing it directly.
- Root · 2 generations backK933455 Computed Oral Radiology SystemSchick Technologies, Inc. · 1994
- 1 generation backK022953 Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2002
- This deviceK072134 Schick Computed Oral Radiology SystemSchick Technologies, Inc. · 2007
- Descendant · cites it directly · 18 of its ownK090526 Medical Image Processing Unit, Model EzsensorE-Woo Technology · 2009
- Descendant · cites it directly · 18 of its ownK090458 Dexis SensorDexis, LLC · 2009
- Descendant · cites it directly · 13 of its ownK103290 Edlen Imaging - Gemini DusbEdlen Imaging, LLC · 2011
- Descendant · cites it directly · 11 of its ownK150823 EDLENi Intra-Oral SensorEdlen Imaging, LLC · 2015
- Descendant · 2 generations on · 10 of its ownK151926 QuickRay HD Intraoral SensorDenterprise International, Inc. · 2015
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K090526Medical Image Processing Unit, Model EzsensorE-Woo Technology · 2009 · cites it directly18descendants
- K090458Dexis SensorDexis, LLC · 2009 · cites it directly18descendants
- K103290Edlen Imaging - Gemini DusbEdlen Imaging, LLC · 2011 · cites it directly13descendants
- K150823EDLENi Intra-Oral SensorEdlen Imaging, LLC · 2015 · cites it directly11descendants
- K151926QuickRay HD Intraoral SensorDenterprise International, Inc. · 2015 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933455 | Computed Oral Radiology System | Schick Technologies, Inc. | 1994 | — |
| −1 | K022953 | Modification to Computed Oral Radiology System | Schick Technologies, Inc. | 2002 | — |
| 0 (this device) | K072134 | Schick Computed Oral Radiology System | Schick Technologies, Inc. | 2007 | — |
| +1 | K090526 | Medical Image Processing Unit, Model Ezsensor | E-Woo Technology | 2009 | — |
| +1 | K090458 | Dexis Sensor | Dexis, LLC | 2009 | — |
| +1 | K103290 | Edlen Imaging - Gemini Dusb | Edlen Imaging, LLC | 2011 | — |
| +1 | K150823 | EDLENi Intra-Oral Sensor | Edlen Imaging, LLC | 2015 | — |
| +2 | K151926 | QuickRay HD Intraoral Sensor | Denterprise International, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
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 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 K242778 X Sensor (Model: IOS-A15IF, HDI-15DGF)score 16.0 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K041385 | Modification to Computed Oral Radiology SystemSummary page 1…t: Daniel Michaeli, Prepared: October 12, 2007 A. Legally Marketed Predicate Devices The Computed Oral Radiology System was most recently cleared on June 7, 2004 under K041385. Other prior clearances include K022953 and K933455. The device and its predicates are small digital imaging receptors that may b… | 2004 |
| * | K022953 | Modification to Computed Oral Radiology SystemSummary page 1…, 2007 A. Legally Marketed Predicate Devices The Computed Oral Radiology System was most recently cleared on June 7, 2004 under K041385. Other prior clearances include K022953 and K933455. The device and its predicates are small digital imaging receptors that may be used in place of dental x-ray film. B… | 2002 |
| * | K933455 | Computed Oral Radiology SystemSummary page 1…egally Marketed Predicate Devices The Computed Oral Radiology System was most recently cleared on June 7, 2004 under K041385. Other prior clearances include K022953 and K933455. The device and its predicates are small digital imaging receptors that may be used in place of dental x-ray film. B. Modificati… | 1994 |
What descends from it? (59)
See all 5912 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090526 | Medical Image Processing Unit, Model Ezsensor | 2009 | 18 |
| K090458 | Dexis Sensor | 2009 | 18 |
| K103290 | Edlen Imaging - Gemini Dusb | 2011 | 13 |
| K150823 | EDLENi Intra-Oral Sensor | 2015 | 11 |
| K220277 | Digital Intraoral X-ray Sensor | 2022 | 2 |
| K092537 | Digital X-Ray Sensor, Model E9539,E9505,E9502, E9540 | 2009 | 2 |
| K133206 | Z-Ray Intra-Oral Digital Radiography System | 2014 | 0 |
| K130088 | Port View, Digital X-Ray Sensor System | 2013 | 0 |
| K112380 | Clearvision | 2011 | 0 |
| K110768 | Computed Dental Radiography | 2011 | 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?
- The line of descent spans 13 years and passes through 1 company; a new generation was cleared every 8.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K090526 (E-Woo Technology, 2009) has gone furthest, with 18 descendants of its own.
- 2 other devices also cite its predicate K041385.
How does its category compare?
All MUH devicesMUH System, X-Ray, Extraoral Source, Digital: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MUH
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUH
159in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUH
1in 2025
MAUDE reports naming product code MUH, 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 | 11 | 48 | 0 | 0 |
| 2008 | 8 | 64 | 1 | 0 |
| 2009 | 9 | 88 | 2 | 12 |
| 2010 | 9 | 174 | 0 | 9 |
| 2011 | 10 | 89 | 0 | 0 |
| 2012 | 9 | 81 | 0 | 5 |
| 2013 | 9 | 172 | 1 | 1 |
| 2014 | 8 | 168 | 1 | 5 |
| 2015 | 12 | 111 | 1 | 3 |
| 2016 | 6 | 47 | 0 | 1 |
| 2017 | 9 | 84 | 0 | 4 |
| 2018 | 3 | 29 | 0 | 10 |
| 2019 | 5 | 64 | 0 | 6 |
| 2020 | 5 | 36 | 0 | 0 |
| 2021 | 10 | 80 | 0 | 1 |
| 2022 | 7 | 57 | 0 | 0 |
| 2023 | 11 | 57 | 0 | 1 |
| 2024 | 4 | 144 | 0 | 0 |
| 2025 | 3 | 159 | 0 | 1 |
| 2026 | 2 | — | 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/K072134 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072134: Schick Computed Oral Radiology System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072134
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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