510(k) · Cleared
ClearedFS Ergo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Palodex Group OY · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Dec 19, 2017 as substantially equivalent to K081925 (Instrumentarium Dental, Palodex Group OY, 2008) and 1 other predicate after a 22-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Dec 19, 2017
- Review
- 22 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K933455 (1994). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK933455 Computed Oral Radiology SystemSchick Technologies, Inc. · 1994
- 5 generations backK022953 Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2002
- 4 generations backK072134 Schick Computed Oral Radiology SystemSchick Technologies, Inc. · 2007
- 3 generations backK090526 Medical Image Processing Unit, Model EzsensorE-Woo Technology · 2009
- 2 generations backK143753 Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor BioRayence Co., Ltd. · 2015
- 1 generation backK151707 EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio iRayence Co., Ltd. · 2015
- This deviceK173646 FS ErgoPalodex Group OY · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K933455 | Computed Oral Radiology System | Schick Technologies, Inc. | 1994 | — |
| −5 | K022953 | Modification to Computed Oral Radiology System | Schick Technologies, Inc. | 2002 | — |
| −4 | K072134 | Schick Computed Oral Radiology System | Schick Technologies, Inc. | 2007 | — |
| −3 | K090526 | Medical Image Processing Unit, Model Ezsensor | E-Woo Technology | 2009 | — |
| −2 | K143753 | Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio | Rayence Co., Ltd. | 2015 | — |
| −1 | K151707 | EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i | Rayence Co., Ltd. | 2015 | — |
| 0 (this device) | K173646 | FS Ergo | Palodex Group OY | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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? (2)
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 |
|---|---|---|---|
| * | K081925 | SnapshotSummary page 4…gy Product Code: MUH Regulation Number: 21 CFR 872.1800 Device Class: Class II Primary Predicate Device Proprietary Name: Snapshot 510(k) Number: K081925 Manufacturer: Instrumentarium Dental, PaloDEX Group Oy Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral so… | 2008 |
| * | K151707 | EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio iSummary page 4…Reference Predicate Device Proprietary Name: EzSensor Soft (EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio I) 510(k) Number: K151707 Manufacturer: Rayence Co., Ltd. Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Produ… | 2015 |
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 23 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- None of the 9 ancestors has a recall.
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. 2017, 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 FS Ergo sensor is a digital sensor which is indicated for acquiring dental intra-oral radiography images. The FS Ergo sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intraoral radiographs.
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/K173646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173646: FS Ergo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173646
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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