510(k) · Cleared
ClearedSterling Diagnostic Imaging Direct Radiography
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterling Diagnostic Imaging, Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Dec 4, 1997 after a 100-day review. The FDA summary names its predicate without a number. 153 later devices descend from it.
- Decided
- Dec 4, 1997
- Review
- 100 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 0
153 later devices descend from it, 5 citing it directly.
- This deviceK973206 Sterling Diagnostic Imaging Direct RadiographySterling Diagnostic Imaging, Inc. · 1997
- Descendant · cites it directly · 141 of its ownK982795 Philips Bucky VisionPhilips Medical Systems, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 103 of its ownK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- Descendant · 2 generations on · 78 of its ownK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- Descendant · 2 generations on · 41 of its ownK090625 Wireless Portable Detector FD-W17Philips Medical Systems North America Co. · 2009 · Recalled
- Descendant · 3 generations on · 34 of its ownK092669 DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · Recalled
Showing 5 of 153 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 153 · See all- K982795Philips Bucky VisionPhilips Medical Systems, Inc. · 1998 · cites it directly141descendants
- K992794Stingray DR, Model 1Infimed, Inc. · 1999 · 2 generations on103descendants
- K024147Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003 · 2 generations on78descendants
- K090625Wireless Portable Detector FD-W17Philips Medical Systems North America Co. · 2009 · 2 generations on41descendants
- K092669DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · 3 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973206 | Sterling Diagnostic Imaging Direct Radiography | Sterling Diagnostic Imaging, Inc. | 1997 | — |
| +1 | K982795 | Philips Bucky Vision | Philips Medical Systems, Inc. | 1998 | 17 |
| +2 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| +2 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| +2 | K090625 | Wireless Portable Detector FD-W17 | Philips Medical Systems North America Co. | 2009 | 28 |
| +3 | K092669 | DX-D Imaging Package | Agfa Healthcare N.V. | 2009 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 6 | 0 |
| 2010 | 7 | 0 |
| 2011 | 10 | 0 |
| 2012 | 5 | 0 |
| 2013 | 11 | 0 |
| 2014 | 12 | 0 |
| 2015 | 5 | 0 |
| 2016 | 11 | 0 |
| 2017 | 12 | 0 |
| 2018 | 5 | 0 |
| 2019 | 9 | 0 |
| 2020 | 7 | 0 |
| 2021 | 12 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | — | Conventional screen-film systems Named without a submission number |
What descends from it? (153)
See all 1535 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?
- Of its descendants, K982795 (Philips Medical Systems, Inc., 1998) has gone furthest, with 141 descendants of its own.
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.
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?
The Direct Radiography™ device provides a digital image capture capability for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The device has application wherever conventional screen-film systems are currently used.
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/K973206 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973206: Sterling Diagnostic Imaging Direct Radiography.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973206
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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