510(k) · Cleared
ClearedReadeR, VieweR, QuickScan PSP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trident S.R.L · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Mar 10, 2016 as substantially equivalent to K143703 (Nical Spa, 2015) after a 28-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Mar 10, 2016
- Review
- 28 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K934949 (1994). No later device cites it as a predicate yet.
- Root · 4 generations backK934949 DigoraOrion Corporation Soredex · 1994
- 3 generations backK041050 Digora Optime (or Digora Ontime)Soredex Palodex Group OY · 2004 · Recalled
- 2 generations backK131442 Firecr Dentalimaging System3Disc Americas · 2013
- 1 generation backK143703 NICAL SMART MICRO CR system for intraoral dental imagesNical Spa · 2015
- This deviceK160386 ReadeR, VieweR, QuickScan PSPTrident S.R.L · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K934949 | Digora | Orion Corporation Soredex | 1994 | — |
| −3 | K041050 | Digora Optime (or Digora Ontime) | Soredex Palodex Group OY | 2004 | 4 |
| −2 | K131442 | Firecr Dentalimaging System | 3Disc Americas | 2013 | — |
| −1 | K143703 | NICAL SMART MICRO CR system for intraoral dental images | Nical Spa | 2015 | — |
| 0 (this device) | K160386 | ReadeR, VieweR, QuickScan PSP | Trident S.R.L | 2016 | — |
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 |
|---|---|---|---|
| * | K143703 | NICAL SMART MICRO CR system for intraoral dental imagesSummary page 5…5.0-1 Predicate Device The subject device claims equivalence to the following legally marketed predicate: 510(k) Number: K143703 Date Cleared March 18, 2015 Trade Name: NICAL SMART MICRO CR System for Intraoral Dental… | 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 22 years and passes through 5 companies; a new generation was cleared every 9.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
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. 2016, 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?
ReadeR is a dental imaging system indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160386 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160386: ReadeR, VieweR, QuickScan PSP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160386
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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