510(k) · Cleared
ClearedKrystalrad New Seriesdigital Radiographic Portable Retrofit System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicatech USA · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on May 17, 2013 as substantially equivalent to K112132 (Medicatech USA, 2011) after a 92-day review. Its family tree reaches back 8 generations to 1990. 1 later device descends from it.
- Decided
- May 17, 2013
- Review
- 92 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K896095 (1990). 27 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 7 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 6 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 5 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 4 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 3 generations backK070618 Dicompacs, Model 5Oehm Und Rehbein GmbH · 2007
- 2 generations backK110040 OmnivisionModern Module, Inc. · 2011
- 1 generation backK112132 Krystalrad 660 Digital Radiographic Portable Retrofit SystemMedicatech USA · 2011
- This deviceK130377 Krystalrad New Seriesdigital Radiographic Portable Retrofit SystemMedicatech USA · 2013
- Descendant · cites it directly · 0 of its ownK230918 MasterX 800 SeriesMedicatech USA · 2023
Most influential descendants
Showing 1 of 1 · See all- K230918MasterX 800 SeriesMedicatech USA · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −7 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −6 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −5 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −4 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −3 | K070618 | Dicompacs, Model 5 | Oehm Und Rehbein GmbH | 2007 | — |
| −2 | K110040 | Omnivision | Modern Module, Inc. | 2011 | — |
| −1 | K112132 | Krystalrad 660 Digital Radiographic Portable Retrofit System | Medicatech USA | 2011 | — |
| 0 (this device) | K130377 | Krystalrad New Seriesdigital Radiographic Portable Retrofit System | Medicatech USA | 2013 | — |
| +1 | K230918 | MasterX 800 Series | Medicatech USA | 2023 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 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 |
|---|---|---|---|
| * | K112132 | Krystalrad 660 Digital Radiographic Portable Retrofit SystemSummary page 1…m Classification Name: Solid state x-ray imager (flat panel/digital imager). MQB Commion/Usual Name: Digital X-Ray Panel 2. Equivalent legally marketed devices: K 112 132. KrystalRad 660. MedicaTech USA. The modified device represents the combination of already cleared devices,… | 2011 |
| † | K122866 | Vivix-S with Vxvue | 2013 |
| † | K122865 | Vivix-S Wireless | 2013 |
| † | K103554 | Metron-CP/MD | 2011 |
| † | K110040 | Omnivision | 2011 |
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 |
|---|---|---|---|
| K230918 | MasterX 800 Series | 2023 | 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 23 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 7 of the 27 ancestors have a recall of any class.
- Of its descendants, K230918 (Medicatech USA, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K112132.
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. 2013, 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 use by a qualified/trained doctor or technologist. As part of a radiographic system, the KrystalRad "New Series" is intended to acquire digital radiographic images. It is suitable for all routine radiography exams, including specialist areas like intensive care or trauma work, excluding fluoroscopy, angiography and mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130377 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130377: Krystalrad New Seriesdigital Radiographic Portable Retrofit System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130377
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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