510(k) · Cleared
ClearedPrimo S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A.T.S. Applicazione Tecnologie Speciali S.R.L. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Jul 9, 2021 as substantially equivalent to K130883 (Sedecal., Sa., 2013) after a 51-day review. Its family tree reaches back 9 generations to 1990.
- Decided
- Jul 9, 2021
- Review
- 51 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K896095 (1990). 30 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 5 generations between
- 3 generations backK110040 OmnivisionModern Module, Inc. · 2011
- 2 generations backK112132 Krystalrad 660 Digital Radiographic Portable Retrofit SystemMedicatech USA · 2011
- 1 generation backK130883 Sedecal Digital Radiographic Upgrade Model Sdru-TSedecal., Sa. · 2013
- This deviceK211542 Primo SA.T.S. Applicazione Tecnologie Speciali S.R.L. · 2021
Show all 9 generations
- Root · 9 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 8 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 7 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 6 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 5 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 4 generations backK070618 Dicompacs, Model 5Oehm Und Rehbein GmbH · 2007
- 3 generations backK110040 OmnivisionModern Module, Inc. · 2011
- 2 generations backK112132 Krystalrad 660 Digital Radiographic Portable Retrofit SystemMedicatech USA · 2011
- 1 generation backK130883 Sedecal Digital Radiographic Upgrade Model Sdru-TSedecal., Sa. · 2013
- This deviceK211542 Primo SA.T.S. Applicazione Tecnologie Speciali S.R.L. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −8 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −7 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −6 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −5 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −4 | K070618 | Dicompacs, Model 5 | Oehm Und Rehbein GmbH | 2007 | — |
| −3 | K110040 | Omnivision | Modern Module, Inc. | 2011 | — |
| −2 | K112132 | Krystalrad 660 Digital Radiographic Portable Retrofit System | Medicatech USA | 2011 | — |
| −1 | K130883 | Sedecal Digital Radiographic Upgrade Model Sdru-T | Sedecal., Sa. | 2013 | — |
| 0 (this device) | K211542 | Primo S | A.T.S. Applicazione Tecnologie Speciali S.R.L. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 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 MQB? 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 MQB device
- #1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 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 |
|---|---|---|---|
| * | K130883 | Sedecal Digital Radiographic Upgrade Model Sdru-TSummary page 4…Number: 21 CFR 892.1680 Regulation Name: Stationary X-ray System Regulatory Class: II Product Code: MQB, IZL Substantially equivalent device: Sedecal SA K130883 Trade/Device Name: Sedecal Digital Radiographic Upgrade Model SDRU-T Regulation Number: 21 CFR 892.1680 Regulation Name:… | 2013 |
| † | K171270 | Digital Radiography Cxdi-410C Wireless | 2017 |
| † | K170332 | Digital Radiography Cxdi-710C Wireless, Digital Radiography Cxdi-810C Wireless | 2017 |
| † | K162687 | Paragon 2 | 2016 |
| † | K201043 | Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) | 2020 |
| † | K201004 | Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat… | 2020 |
| † | K123644 | Vizion + DR | 2013 |
| † | K210316 | Mars 1417X Wireless Digital Flat Panel Detector | 2021 |
| † | K210314 | Mars1717X Wireless Digital Flat Panel Detector | 2021 |
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 31 years and passes through 8 companies; a new generation was cleared every 2.8 years on median.
- 7 of the 30 ancestors have a recall of any class.
- 3 other devices also cite its predicate K130883.
How does its category compare?
All MQB devicesMQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · MQB
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQB
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQB
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQB
141in 2025
MAUDE reports naming product code MQB, 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 | 13 | 22 | 15 | 25 |
| 2008 | 8 | 15 | 36 | 30 |
| 2009 | 15 | 57 | 19 | 34 |
| 2010 | 11 | 116 | 14 | 39 |
| 2011 | 24 | 102 | 10 | 101 |
| 2012 | 22 | 80 | 8 | 267 |
| 2013 | 21 | 105 | 6 | 159 |
| 2014 | 32 | 102 | 0 | 29 |
| 2015 | 21 | 81 | 0 | 21 |
| 2016 | 22 | 92 | 0 | 26 |
| 2017 | 31 | 30 | 1 | 20 |
| 2018 | 16 | 30 | 4 | 84 |
| 2019 | 22 | 30 | 1 | 45 |
| 2020 | 19 | 28 | 4 | 9 |
| 2021 | 21 | 48 | 1 | 26 |
| 2022 | 31 | 48 | 0 | 13 |
| 2023 | 10 | 30 | 0 | 51 |
| 2024 | 8 | 187 | 0 | 91 |
| 2025 | 8 | 127 | 1 | 141 |
| 2026 | 3 | 245 | 1 | — |
What is it indicated for?
Intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. The kit allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211542 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211542: Primo S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211542
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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