510(k) · Cleared
Recalled · Class II · 2025DR 800 with Tomosynthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa N.V. · IZF System, X-Ray, Tomographic
Cleared on Feb 1, 2019 as substantially equivalent to K132261 (Ge Medical Systems, LLC, 2013) and 1 other predicate after a 70-day review. Its family tree reaches back 6 generations to 1986. 8 later devices descend from it. It has been recalled 3 times.
- Decided
- Feb 1, 2019
- Review
- 70 days
- Class
- Class II
- Product code
- IZF
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 6 generations to K862120 (1986). 10 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 5 generations backK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- 4 generations backK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- 3 generations backK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
- 2 generations backK051967 Revolution XR/D Digital Radiographic Imaging System with TomosynthesisGE Healthcare · 2005 · Recalled
- 1 generation backK132261 Discovery XR656 with Volumerad (Digital Tomosynthesis)Ge Medical Systems, LLC · 2013 · Recalled
- This deviceK183275 DR 800 with TomosynthesisAgfa N.V. · 2019
- Descendant · cites it directly · 4 of its ownK193262 DR 600 with TomosynthesisAgfa N.V. · 2020
- Descendant · 2 generations on · 3 of its ownK222934 Nanox.ARCNano-X Imaging, Ltd. · 2023
- Descendant · 3 generations on · 2 of its ownK242395 Nanox.ARCNano-X Imaging, Ltd. · 2024
- Descendant · 4 generations on · 1 of its ownK250850 Nanox.ARC XNano-X Imaging, Ltd. · 2025
- Descendant · cites it directly · 1 of its ownK221949 Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemPausch Medical GmbH · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K193262DR 600 with TomosynthesisAgfa N.V. · 2020 · cites it directly4descendants
- K222934Nanox.ARCNano-X Imaging, Ltd. · 2023 · 2 generations on3descendants
- K242395Nanox.ARCNano-X Imaging, Ltd. · 2024 · 3 generations on2descendants
- K250850Nanox.ARC XNano-X Imaging, Ltd. · 2025 · 4 generations on1descendant
- K221949Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemPausch Medical GmbH · 2023 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −5 | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| −4 | K992066 | Revolution TX/I Digital Radiographic Table System | GE Medical Systems | 1999 | — |
| −3 | K012389 | Revolution XR/D Digital Radiographic Imaging System | Ge Medical Systems, Inc. | 2001 | 4 |
| −2 | K051967 | Revolution XR/D Digital Radiographic Imaging System with Tomosynthesis | GE Healthcare | 2005 | 9 |
| −1 | K132261 | Discovery XR656 with Volumerad (Digital Tomosynthesis) | Ge Medical Systems, LLC | 2013 | 1 |
| 0 (this device) | K183275 | DR 800 with Tomosynthesis | Agfa N.V. | 2019 | — |
| +1 | K193262 | DR 600 with Tomosynthesis | Agfa N.V. | 2020 | — |
| +2 | K222934 | Nanox.ARC | Nano-X Imaging, Ltd. | 2023 | — |
| +3 | K242395 | Nanox.ARC | Nano-X Imaging, Ltd. | 2024 | — |
| +4 | K250850 | Nanox.ARC X | Nano-X Imaging, Ltd. | 2025 | — |
| +1 | K221949 | Ortho Device, ADAPTIX 3D Orthopedic Imaging System | Pausch Medical GmbH | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K132261 | Discovery XR656 with Volumerad (Digital Tomosynthesis)Summary page 6…s is a 510(k) for Agfa’s DR 800, which is tomographic and fluoroscopic x-ray system. It is substantially equivalent to GE Medical System’s Discover XR656 with VolumeRAD (K132261) and Agfa’s previous version of the DR 800 with MUSICA Dynamic (K180589). Primary Predicate: Name of Device: Discover XR656 with… | 2013 |
| * | K180589 | DR 800 with MUSICA DynamicSummary page 6…-ray system. It is substantially equivalent to GE Medical System’s Discover XR656 with VolumeRAD (K132261) and Agfa’s previous version of the DR 800 with MUSICA Dynamic (K180589). Primary Predicate: Name of Device: Discover XR656 with VolumeRAD Common Name: System, X-Ray, Tomographic Classification Name:… | 2018 |
What descends from it? (8)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 18, 2025 | Class II | Z-0923-2026 | Radiation Control for Health and Safety Act | It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled. |
| Jul 29, 2024 | Class II | Z-2738-2024 | Device Design | Potential for the front lever chain of the DR 800 table to fail. |
| Feb 10, 2020 | Class II | Z-1502-2020 | Under Investigation by firm | Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 6 companies; a new generation was cleared every 5.2 years on median.
- 6 of the 10 ancestors have a recall of any class.
- Of its descendants, K193262 (Agfa N.V., 2020) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K132261.
How does its category compare?
All IZF devicesIZF System, X-Ray, Tomographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures: • Positioning fluoroscopy procedures • Gastro-intestinal examinations • Urogenital tract examinations • Angiography It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts. In addition, the…
Read the full statement (106 words)
The DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures:
• Positioning fluoroscopy procedures
• Gastro-intestinal examinations
• Urogenital tract examinations
• Angiography
It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts.
In addition, the system provides the Agfa Tomosynthesis option, which is intended to acquire tomographic slices of human anatomy and to be used with Agfa DR X-Ray systems. Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep.
The DR 800 is not intended for mammography applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183275 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183275: DR 800 with Tomosynthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183275
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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