510(k) · Cleared
ClearedDigital Imaging System (BSR)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · IZI System, X-Ray, Angiographic
Cleared on Sep 1, 1999 as substantially equivalent to K933664 (Siemens Gammasonics, Inc., 1993) and 1 other predicate after an 86-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Sep 1, 1999
- Review
- 86 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K933664 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK933664 Polytron T.O.P. (Time, Operation, Performance)Siemens Gammasonics, Inc. · 1993
- This deviceK991922 Digital Imaging System (BSR)Siemens Medical Solutions USA, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933664 | Polytron T.O.P. (Time, Operation, Performance) | Siemens Gammasonics, Inc. | 1993 | — |
| 0 (this device) | K991922 | Digital Imaging System (BSR) | Siemens Medical Solutions USA, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 IZI? 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 IZI device
- #1 K230727 SPY Portable Handheld Imaging (SPY-PHI) Systemscore 23.2 · 20 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 |
|---|---|---|---|
| * | K933664 | Polytron T.O.P. (Time, Operation, Performance)Summary page 1…of the device. Substantial Equivalence: The Digital Imaging System (BSR), is substantially equivalent to currently marketed Siemens Medical Systems, Inc. Polytron TOP (K933664) and Phillips Integris Series (K984545). Contact: Robert W. Callahan Manager of Regulatory Affairs Siemens Medical Systems, I… | 1993 |
| * | K984545 | Release 2 of Philips Integris Series (V5000, BV5000, H5000, BH5000, HM2000) SystemsSummary page 1…: The Digital Imaging System (BSR), is substantially equivalent to currently marketed Siemens Medical Systems, Inc. Polytron TOP (K933664) and Phillips Integris Series (K984545). Contact: Robert W. Callahan Manager of Regulatory Affairs Siemens Medical Systems, Inc. Nuclear Medicine Group 2501 North… | 1999 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K933664.
How does its category compare?
All IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZI
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZI
81in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZI
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZI
2,171in 2025
MAUDE reports naming product code IZI, 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 | 7 | 28 | 6 | 92 |
| 2008 | 6 | 68 | 52 | 101 |
| 2009 | 2 | — | 18 | 132 |
| 2010 | 2 | — | 11 | 252 |
| 2011 | 4 | 104 | 6 | 377 |
| 2012 | 1 | — | 6 | 77 |
| 2013 | 1 | — | 6 | 58 |
| 2014 | 4 | 111 | 5 | 123 |
| 2015 | 0 | — | 14 | 36 |
| 2016 | 1 | — | 7 | 102 |
| 2017 | 2 | — | 1 | 88 |
| 2018 | 2 | — | 2 | 49 |
| 2019 | 2 | — | 2 | 30 |
| 2020 | 1 | — | 2 | 14 |
| 2021 | 1 | — | 1 | 29 |
| 2022 | 1 | — | 0 | 265 |
| 2023 | 3 | 81 | 0 | 1,204 |
| 2024 | 2 | — | 0 | 1,332 |
| 2025 | 2 | — | 0 | 2,171 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Digital Imaging Systems (BSR), are intended for use in acquiring diagnosic quality images during cardiac, angiographic, vascular and neurovascular applications.
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/K991922 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991922: Digital Imaging System (BSR).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991922
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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