510(k) · Cleared
ClearedRXS 1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rolence Enterprise, Inc. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Sep 15, 2021 as substantially equivalent to K163282 (Masterlink, LLC, 2017) after a 392-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Sep 15, 2021
- Review
- 392 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K933455 (1994). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK933455 Computed Oral Radiology SystemSchick Technologies, Inc. · 1994
- 6 generations backK022953 Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2002
- 5 generations backK072134 Schick Computed Oral Radiology SystemSchick Technologies, Inc. · 2007
- 4 generations backK103290 Edlen Imaging - Gemini DusbEdlen Imaging, LLC · 2011
- 3 generations backK150823 EDLENi Intra-Oral SensorEdlen Imaging, LLC · 2015
- 2 generations backK151926 QuickRay HD Intraoral SensorDenterprise International, Inc. · 2015
- 1 generation backK163282 Apex Dental SensorsMasterlink, LLC · 2017
- This deviceK202369 RXS 1000Rolence Enterprise, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K933455 | Computed Oral Radiology System | Schick Technologies, Inc. | 1994 | — |
| −6 | K022953 | Modification to Computed Oral Radiology System | Schick Technologies, Inc. | 2002 | — |
| −5 | K072134 | Schick Computed Oral Radiology System | Schick Technologies, Inc. | 2007 | — |
| −4 | K103290 | Edlen Imaging - Gemini Dusb | Edlen Imaging, LLC | 2011 | — |
| −3 | K150823 | EDLENi Intra-Oral Sensor | Edlen Imaging, LLC | 2015 | — |
| −2 | K151926 | QuickRay HD Intraoral Sensor | Denterprise International, Inc. | 2015 | — |
| −1 | K163282 | Apex Dental Sensors | Masterlink, LLC | 2017 | — |
| 0 (this device) | K202369 | RXS 1000 | Rolence Enterprise, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 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 |
|---|---|---|---|
| * | K163282 | Apex Dental SensorsSummary page 4…urce, Digital Classification: Class II per 21 CFR 872.1800 Product Code: MUH Classification Panel: Dental Predicate Device Information: 510(k) Number: K163282 Trade Name: Apex Dental Sensors Size #1 Common Name: Intraoral Digital X-ray Sensor Classification Name: System, X-Ra… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- None of the 15 ancestors has a recall.
- 1 other device also cites its predicate K163282.
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. 2021, 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 RXS 1000 is an Intraoral Digital X-ray Sensor and is intended to be used by dentists and dental technicians diagnostic diseases of the teeth, jaw and oral structures. Its use is intended for adult subjects.
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/K202369 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202369: RXS 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202369
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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