510(k) · Cleared
ClearedBrasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Realcloud Imaging Inc. Dba Realcloud Imaging · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Aug 31, 2022 as substantially equivalent to K202664 (Sota Precision Optics, Inc. Dba Sota Imaging, 2020) after a 57-day review. Its family tree reaches back 5 generations to 1994. 1 later device descends from it.
- Decided
- Aug 31, 2022
- Review
- 57 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K933455 (1994). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK933455 Computed Oral Radiology SystemSchick Technologies, Inc. · 1994
- 4 generations backK022953 Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2002
- 3 generations backK072134 Schick Computed Oral Radiology SystemSchick Technologies, Inc. · 2007
- 2 generations backK090458 Dexis SensorDexis, LLC · 2009
- 1 generation backK202664 Clio Prime and Clio PedoSota Precision Optics, Inc. Dba Sota Imaging · 2020
- This deviceK221955 Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20Realcloud Imaging Inc. Dba Realcloud Imaging · 2022
- Descendant · cites it directly · 0 of its ownK241649 DUO1 and DUO2Zinnovi, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K241649DUO1 and DUO2Zinnovi, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933455 | Computed Oral Radiology System | Schick Technologies, Inc. | 1994 | — |
| −4 | K022953 | Modification to Computed Oral Radiology System | Schick Technologies, Inc. | 2002 | — |
| −3 | K072134 | Schick Computed Oral Radiology System | Schick Technologies, Inc. | 2007 | — |
| −2 | K090458 | Dexis Sensor | Dexis, LLC | 2009 | — |
| −1 | K202664 | Clio Prime and Clio Pedo | Sota Precision Optics, Inc. Dba Sota Imaging | 2020 | — |
| 0 (this device) | K221955 | Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 | Realcloud Imaging Inc. Dba Realcloud Imaging | 2022 | — |
| +1 | K241649 | DUO1 and DUO2 | Zinnovi, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K202664 | Clio Prime and Clio PedoSummary page 5…A Precision Optics, Inc. doing business as SOTA Imaging Owner/Operator Number: 905754 Establishment Registration Number: 3000190675 510(k) Premarket Notification Number: K202664 Trade Name: Clio Prime Common Name: Dental intraoral x-ray sensor Classification Name: Extra-oral source x-ray system Product Cod… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241649 | DUO1 and DUO2 | 2024 | 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 28 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K241649 (Zinnovi, Inc., 2024) has gone furthest, with 0 descendants of its own.
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. 2022, 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?
Brasseler GEM is a USB-driven digital intraoral x-ray sensor which is intended to acquire dental radiographic images. Brasseler GEM must be operated by healthcare professionals who have been trained and are competent using various methods of acquiring radiographic images of dental anatomy. Brasseler GEM can be used with dental positioning devices and holders to assist with aligning an x-ray source beam with the sensor and anatomy. Brasseler GEM can also be aligned by hand with assistance of patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221955 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221955: Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221955
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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