510(k) · Cleared
ClearedMicro X-80 HF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fischer Imaging Corp. · IZO Generator, High-Voltage, X-Ray, Diagnostic
Cleared on Sep 16, 1994 after a 22-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 9 later devices descend from it.
- Decided
- Sep 16, 1994
- Review
- 22 days
- Class
- Class I
- Product code
- IZO
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK944149 Micro X-80 HFFischer Imaging Corp. · 1994
- Descendant · cites it directly · 8 of its ownK980970 Iirad Directray Operator ConsoleSterling Diagnostic Imaging, Inc. · 1998
- Descendant · 2 generations on · 3 of its ownK033345 AN5150 and AN7150 Digital Radiology SystemsAnalogic Corp. · 2003
- Descendant · 2 generations on · 2 of its ownK063188 Del-ImsDel Medical Imaging Corp. · 2006
- Descendant · 3 generations on · 2 of its ownK040995 Synerad Multi Digital X-Ray System, Model AN6150Analogic Corp. · 2004 · Recalled
- Descendant · 3 generations on · 1 of its ownK093480 Cuattro UnomdCuattro, LLC · 2010
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K980970Iirad Directray Operator ConsoleSterling Diagnostic Imaging, Inc. · 1998 · cites it directly8descendants
- K033345AN5150 and AN7150 Digital Radiology SystemsAnalogic Corp. · 2003 · 2 generations on3descendants
- K063188Del-ImsDel Medical Imaging Corp. · 2006 · 2 generations on2descendants
- K040995Synerad Multi Digital X-Ray System, Model AN6150Analogic Corp. · 2004 · 3 generations on2descendants
- K093480Cuattro UnomdCuattro, LLC · 2010 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944149 | Micro X-80 HF | Fischer Imaging Corp. | 1994 | — |
| +1 | K980970 | Iirad Directray Operator Console | Sterling Diagnostic Imaging, Inc. | 1998 | — |
| +2 | K033345 | AN5150 and AN7150 Digital Radiology Systems | Analogic Corp. | 2003 | — |
| +2 | K063188 | Del-Ims | Del Medical Imaging Corp. | 2006 | — |
| +3 | K040995 | Synerad Multi Digital X-Ray System, Model AN6150 | Analogic Corp. | 2004 | 1 |
| +3 | K093480 | Cuattro Unomd | Cuattro, LLC | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IZO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980970 | Iirad Directray Operator Console | 1998 | 8 |
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, K980970 (Sterling Diagnostic Imaging, Inc., 1998) has gone furthest, with 8 descendants of its own.
How does its category compare?
All IZO devicesIZO Generator, High-Voltage, X-Ray, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZO
FDA has decided no IZO device since 2007.
Median 510(k) review, days · IZO
Too few IZO 510(k)s in any year since 2007 to give a median.
Recalls per year · IZO
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZO
3in 2023
MAUDE reports naming product code IZO, 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 | — | 1 | 3 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 1 | 15 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K944149 · printed Nov 4, 2026
Cite this page
510(k) Report. “K944149: Micro X-80 HF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K944149
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026