510(k) · Cleared
ClearedOrtho Device, ADAPTIX 3D Orthopedic Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pausch Medical GmbH · IZF System, X-Ray, Tomographic
Cleared on Jan 26, 2023 as substantially equivalent to K183275 (Agfa N.V., 2019) and 1 other predicate after a 205-day review. Its family tree reaches back 7 generations to 1986. 1 later device descends from it.
- Decided
- Jan 26, 2023
- Review
- 205 days
- Class
- Class II
- Product code
- IZF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K862120 (1986). 12 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 6 generations backK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- 5 generations backK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- 4 generations backK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
- 3 generations backK051967 Revolution XR/D Digital Radiographic Imaging System with TomosynthesisGE Healthcare · 2005 · Recalled
- 2 generations backK132261 Discovery XR656 with Volumerad (Digital Tomosynthesis)Ge Medical Systems, LLC · 2013 · Recalled
- 1 generation backK183275 DR 800 with TomosynthesisAgfa N.V. · 2019 · Recalled
- This deviceK221949 Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemPausch Medical GmbH · 2023
- Descendant · cites it directly · 0 of its ownK252133 Adaptix Ortho350Adaptix Limited · 2025
Most influential descendants
Showing 1 of 1 · See all- K252133Adaptix Ortho350Adaptix Limited · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −6 | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| −5 | K992066 | Revolution TX/I Digital Radiographic Table System | GE Medical Systems | 1999 | — |
| −4 | K012389 | Revolution XR/D Digital Radiographic Imaging System | Ge Medical Systems, Inc. | 2001 | 4 |
| −3 | K051967 | Revolution XR/D Digital Radiographic Imaging System with Tomosynthesis | GE Healthcare | 2005 | 9 |
| −2 | K132261 | Discovery XR656 with Volumerad (Digital Tomosynthesis) | Ge Medical Systems, LLC | 2013 | 1 |
| −1 | K183275 | DR 800 with Tomosynthesis | Agfa N.V. | 2019 | 3 |
| 0 (this device) | K221949 | Ortho Device, ADAPTIX 3D Orthopedic Imaging System | Pausch Medical GmbH | 2023 | — |
| +1 | K252133 | Adaptix Ortho350 | Adaptix Limited | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 IZF? 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 IZF device
- #1 K250850 Nanox.ARC Xscore 15.5 · 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? (2)
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 |
|---|---|---|---|
| * | K183275 | DR 800 with TomosynthesisSummary page 4…system Product Code: IZF Tomographic x-ray system Subsequent Product Code: JAA fluoroscopic, image-intensified x-ray system 510(k) number: K183275 Manufacturer: Agfa N.V. Secondary predicate device Device name: OrthoScan Mobile DI Mini C-Arm… | 2019 |
| * | K113708 | Orthoscan Mobile DI Mini C-ArmSummary page 4…OXA mobile image-intensified fluoroscopic x-ray system Subsequent Product Code: JAA fluoroscopic, image-intensified x-ray system 510(k) number: K113708 Manufacturer: ORTHOSCAN, INC. Page 1 of 5… | 2012 |
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 |
|---|---|---|---|
| K252133 | Adaptix Ortho350 | 2025 | 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 37 years and passes through 7 companies; a new generation was cleared every 4.0 years on median.
- 8 of the 12 ancestors have a recall of any class.
- Of its descendants, K252133 (Adaptix Limited, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K183275.
How does its category compare?
All IZF devicesIZF System, X-Ray, Tomographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · IZF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZF
Too few IZF 510(k)s in any year since 2007 to give a median.
Recalls per year · IZF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZF
1in 2021
MAUDE reports naming product code IZF, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 24 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 1 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Ortho Device is intended to generate tomosynthesis images of human anatomy for diagnostic purposes of the hand, elbow and foot in patients of all ages.
The imaging will provide the physician visualized information about anatomical structures to facilitate assessment in orthopedic cases such as:
• Fractures of bones in finger, metacarpus or wrist
• Fractures of foot, ankle or elbow joint
• Arthritis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221949 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221949: Ortho Device, ADAPTIX 3D Orthopedic Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221949
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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