510(k) · Cleared
ClearedModification to 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 Oct 2, 2002 as substantially equivalent to K933455 (Schick Technologies, Inc., 1994) after a 27-day review. Its family tree reaches back 1 generation to 1994. 106 later devices descend from it.
- Decided
- Oct 2, 2002
- Review
- 27 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933455 (1994). 106 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK933455 Computed Oral Radiology SystemSchick Technologies, Inc. · 1994
- This deviceK022953 Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2002
- Descendant · cites it directly · 59 of its ownK072134 Schick Computed Oral Radiology SystemSchick Technologies, Inc. · 2007
- Descendant · cites it directly · 44 of its ownK070505 Krystal-X WifiOwandy · 2007
- Descendant · 2 generations on · 43 of its ownK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 32 of its ownK121513 Multix FusionSiemens Medical Solution · 2012 · Recalled
- Descendant · 3 generations on · 23 of its ownK133259 Ysio MaxSiemens Medical Solutions USA, Inc. · 2014 · Recalled
Showing 5 of 106 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 106 · See all- K072134Schick Computed Oral Radiology SystemSchick Technologies, Inc. · 2007 · cites it directly59descendants
- K070505Krystal-X WifiOwandy · 2007 · cites it directly44descendants
- K081722YSIOSiemens Medical Solutions USA, Inc. · 2008 · 2 generations on43descendants
- K121513Multix FusionSiemens Medical Solution · 2012 · 3 generations on32descendants
- K133259Ysio MaxSiemens Medical Solutions USA, Inc. · 2014 · 3 generations on23descendants
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) | K022953 | Modification to Computed Oral Radiology System | Schick Technologies, Inc. | 2002 | — |
| +1 | K072134 | Schick Computed Oral Radiology System | Schick Technologies, Inc. | 2007 | — |
| +1 | K070505 | Krystal-X Wifi | Owandy | 2007 | — |
| +2 | K081722 | YSIO | Siemens Medical Solutions USA, Inc. | 2008 | 11 |
| +3 | K121513 | Multix Fusion | Siemens Medical Solution | 2012 | 4 |
| +3 | K133259 | Ysio Max | Siemens Medical Solutions USA, Inc. | 2014 | 7 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 6 | 0 |
| 2015 | 9 | 0 |
| 2016 | 5 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 7 | 0 |
| 2020 | 8 | 0 |
| 2021 | 10 | 0 |
| 2022 | 6 | 0 |
| 2023 | 10 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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? (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 | Decided |
|---|---|---|---|
| * | K933455 | Computed Oral Radiology SystemSummary page 1…Michaeli, Prepared: September 4, 2002 A. Legally Marketed Predicate Devices The original Computed Oral Radiology System notification was cleared on January 3Is‘, 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… | 1994 |
What descends from it? (106)
See all 1064 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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.
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 as stated in the FDA summary.
https://510kreport.com/device/K022953 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022953: Modification to 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/K022953
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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