510(k) · Cleared
ClearedDR 800 with DSA, DR 800
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa N.V. · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Aug 31, 2021 as substantially equivalent to K190373 (Shimadzu Corporation, 2019) and 1 other predicate after a 53-day review. Its family tree reaches back 8 generations to 1986.
- Decided
- Aug 31, 2021
- Review
- 53 days
- Class
- Class II
- Product code
- JAA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K862120 (1986). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 7 generations backK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- 6 generations backK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- 5 generations backK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
- 4 generations backK051967 Revolution XR/D Digital Radiographic Imaging System with TomosynthesisGE Healthcare · 2005 · Recalled
- 3 generations backK132261 Discovery XR656 with Volumerad (Digital Tomosynthesis)Ge Medical Systems, LLC · 2013 · Recalled
- 2 generations backK142341 X-Ray TV System Sonialvision G4Shimadzu Corp. · 2015 · Recalled
- 1 generation backK190373 SonialVision G4Shimadzu Corporation · 2019 · Recalled
- This deviceK212145 DR 800 with DSA, DR 800Agfa N.V. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −7 | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| −6 | K992066 | Revolution TX/I Digital Radiographic Table System | GE Medical Systems | 1999 | — |
| −5 | K012389 | Revolution XR/D Digital Radiographic Imaging System | Ge Medical Systems, Inc. | 2001 | 4 |
| −4 | K051967 | Revolution XR/D Digital Radiographic Imaging System with Tomosynthesis | GE Healthcare | 2005 | 9 |
| −3 | K132261 | Discovery XR656 with Volumerad (Digital Tomosynthesis) | Ge Medical Systems, LLC | 2013 | 1 |
| −2 | K142341 | X-Ray TV System Sonialvision G4 | Shimadzu Corp. | 2015 | 2 |
| −1 | K190373 | SonialVision G4 | Shimadzu Corporation | 2019 | 2 |
| 0 (this device) | K212145 | DR 800 with DSA, DR 800 | Agfa N.V. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 2005 | 2 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 JAA? 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 JAA device
- #1 K253103 Nexus DRF Digital X-ray Imaging Systemscore 13.2 · 7 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 |
|---|---|---|---|
| * | K190373 | SonialVision G4Summary page 4…hich is a fluoroscopic x-ray system, including digital angiography. It is substantially equivalent to Shimadzu Corporation’s primary predicate device A, SONIALVISION G4 (K190373) and Agfa’s predicate device B, DR 800 with Tomosynthesis (K183275). 1. Primary Predicate Device (A): SONIALVISION G4 Common N… | 2019 |
| * | K183275 | DR 800 with TomosynthesisSummary page 4…It is substantially equivalent to Shimadzu Corporation’s primary predicate device A, SONIALVISION G4 (K190373) and Agfa’s predicate device B, DR 800 with Tomosynthesis (K183275). 1. Primary Predicate Device (A): SONIALVISION G4 Common Name: System, X-Ray, Fluoroscopic Image-Intensified Classification… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 8 companies; a new generation was cleared every 4.0 years on median.
- 10 of the 16 ancestors have a recall of any class.
- 2 other devices also cite its predicate K190373.
How does its category compare?
All JAA devicesJAA System, X-Ray, Fluoroscopic, Image-Intensified: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · JAA
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAA
89in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAA
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAA
33in 2025
MAUDE reports naming product code JAA, 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 | 1 | — | 35 | 9,517 |
| 2008 | 6 | 18 | 21 | 9,484 |
| 2009 | 0 | — | 18 | 12,040 |
| 2010 | 1 | — | 6 | 5,803 |
| 2011 | 4 | 48 | 7 | 14,000 |
| 2012 | 1 | — | 2 | 11,684 |
| 2013 | 6 | 129 | 3 | 13,706 |
| 2014 | 6 | 276 | 1 | 10,265 |
| 2015 | 3 | 197 | 1 | 2,922 |
| 2016 | 2 | — | 7 | 35 |
| 2017 | 1 | — | 3 | 56 |
| 2018 | 3 | 30 | 1 | 36 |
| 2019 | 6 | 49 | 2 | 49 |
| 2020 | 4 | 39 | 2 | 39 |
| 2021 | 6 | 104 | 2 | 35 |
| 2022 | 1 | — | 5 | 34 |
| 2023 | 2 | — | 9 | 41 |
| 2024 | 3 | 89 | 2 | 25 |
| 2025 | 2 | — | 4 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The DR 800 with DSA 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 • Digital Subtraction Angiography It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for projection…
Read the full statement (117 words)
The DR 800 with DSA 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
• Digital Subtraction Angiography
It is intended to replace fluoroscopic images obtained through image intensifier technology.
In addition, the system is intended for projection 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. Digital Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep.
Not intended for cardiovascular and cerebrovascular contrast studies.
Not intended for mammography applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212145: DR 800 with DSA, DR 800.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212145
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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