510(k) · Cleared
ClearedKrystalrad 660 Digital 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 Nov 18, 2011 as substantially equivalent to K080582 (Medicatech USA, 2008) and 2 other predicates after a 115-day review. Its family tree reaches back 7 generations to 1990. 14 later devices descend from it.
- Decided
- Nov 18, 2011
- Review
- 115 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K896095 (1990). 26 ancestors in all. 14 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 6 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 5 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 4 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 3 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 2 generations backK070618 Dicompacs, Model 5Oehm Und Rehbein GmbH · 2007
- 1 generation backK110040 OmnivisionModern Module, Inc. · 2011
- This deviceK112132 Krystalrad 660 Digital Radiographic Portable Retrofit SystemMedicatech USA · 2011
- Descendant · cites it directly · 11 of its ownK130883 Sedecal Digital Radiographic Upgrade Model Sdru-TSedecal., Sa. · 2013
- Descendant · 2 generations on · 7 of its ownK140825 Delworks DR SystemDel Medical, Inc. · 2014
- Descendant · 2 generations on · 6 of its ownK162529 DigiX FDXAllengers Medical Systems Limited · 2017
- Descendant · 3 generations on · 5 of its ownK192541 DigiX FDXAllengers Medical Systems Limited · 2019
- Descendant · 4 generations on · 4 of its ownK223060 DigiX FDXAllengers Medical Systems Limited · 2022
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K130883Sedecal Digital Radiographic Upgrade Model Sdru-TSedecal., Sa. · 2013 · cites it directly11descendants
- K140825Delworks DR SystemDel Medical, Inc. · 2014 · 2 generations on7descendants
- K162529DigiX FDXAllengers Medical Systems Limited · 2017 · 2 generations on6descendants
- K192541DigiX FDXAllengers Medical Systems Limited · 2019 · 3 generations on5descendants
- K223060DigiX FDXAllengers Medical Systems Limited · 2022 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −6 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −5 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −4 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −3 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −2 | K070618 | Dicompacs, Model 5 | Oehm Und Rehbein GmbH | 2007 | — |
| −1 | K110040 | Omnivision | Modern Module, Inc. | 2011 | — |
| 0 (this device) | K112132 | Krystalrad 660 Digital Radiographic Portable Retrofit System | Medicatech USA | 2011 | — |
| +1 | K130883 | Sedecal Digital Radiographic Upgrade Model Sdru-T | Sedecal., Sa. | 2013 | — |
| +2 | K140825 | Delworks DR System | Del Medical, Inc. | 2014 | — |
| +2 | K162529 | DigiX FDX | Allengers Medical Systems Limited | 2017 | — |
| +3 | K192541 | DigiX FDX | Allengers Medical Systems Limited | 2019 | — |
| +4 | K223060 | DigiX FDX | Allengers Medical Systems Limited | 2022 | — |
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 |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K080582 | Medicatech, Model DDR Mak-800, DDT Mak-1000 FS, DDR Mak-1100 FASummary page 1…/digital imager), MQB Common/Usual Name: Digital X-Ray Pancl Equivalent legally marketed devices: * The image processing sofiware is the same as provided in our 510(k) K080582 DDR MAK . Series. Alternately the image processing sofiware is the same asinOmniVision, K 1100403 madc by Modern Module Inc. * T… | 2008 |
| * | K110040 | OmnivisionSummary page 1…s: * The image processing sofiware is the same as provided in our 510(k) K080582 DDR MAK . Series. Alternately the image processing sofiware is the same asinOmniVision, K 1100403 madc by Modern Module Inc. * The Detector is identical to the Wireless Portable Detector FD-W|7 (K090625) marketed by Philips M… | 2011 |
| * | K090625 | Wireless Portable Detector FD-W17Summary page 1…ely the image processing sofiware is the same asinOmniVision, K 1100403 madc by Modern Module Inc. * The Detector is identical to the Wireless Portable Detector FD-W|7 (K090625) marketed by Philips Mcdical Systems . Description of the Device: This device is simply the combination of two cleared devices,… | 2009 |
| † | K063781 | Philips XD-S Direct Radiography Workstation/Package | 2007 |
What descends from it? (14)
See all 142 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 7 of the 26 ancestors have a recall of any class.
- Of its descendants, K130883 (Sedecal., Sa., 2013) has gone furthest, with 11 descendants of its own.
- 1 other device also cites its predicate K080582.
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. 2011, 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 660 is intended to acquire digital radiographic images. It is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.
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/K112132 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112132: Krystalrad 660 Digital 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/K112132
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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