510(k) · Cleared
ClearedProxiscan Model 101
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hybridyne Imaging Technologies, Inc. · IYX Camera, Scintillation (Gamma)
Cleared on Apr 2, 2010 as substantially equivalent to K022342 (Anzai Medical Co., Ltd., 2002) and 1 other predicate after a 122-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Apr 2, 2010
- Review
- 122 days
- Class
- Class I
- Product code
- IYX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K935595 (1995). 31 ancestors in all, the oldest K885054 (1989). No later device cites it as a predicate yet.
- Root · 7 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 6 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 5 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 4 generations backK032111 Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 3 generations backK040060 Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
- 2 generations backK050034 Sonoline Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 1 generation backK060879 Model EC9-4 TransducerSiemens Medical Solutions USA, Inc. · 2006
- This deviceK093706 Proxiscan Model 101Hybridyne Imaging Technologies, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −6 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −5 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −4 | K032111 | Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2003 | 1 |
| −3 | K040060 | Sonoline G50 and G60 S Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −2 | K050034 | Sonoline Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −1 | K060879 | Model EC9-4 Transducer | Siemens Medical Solutions USA, Inc. | 2006 | — |
| 0 (this device) | K093706 | Proxiscan Model 101 | Hybridyne Imaging Technologies, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1997 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2002 | 3 | 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 IYX? 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 IYX device
- #1 K230221 QDOSE® Multi-purpose Voxel Dosimetry…score 6.2 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K022342 | EZ-Scope an, EZ-Scope LightSummary page 1…uct Code: IYX) PREDICATE DEVICE(S): Anzai Medical Company, Ltd. Anzai eZScope AN Portable Gamma Camera (K022342) and the Siemens Medical Solutions USA, Inc EC9-4 Ultrasound… | 2002 |
| * | K060879 | Model EC9-4 TransducerSummary page 1…a (K022342) and the Siemens Medical Solutions USA, Inc EC9-4 Ultrasound Transducer (K060879) DEVICE DESCRIPTION: The ProxiScanTM is an imaging device cons… | 2006 |
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 15 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 8 of the 31 ancestors have a recall of any class.
- 1 other device also cites its predicate K022342.
How does its category compare?
All IYX devicesIYX Camera, Scintillation (Gamma): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · IYX
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · IYX
82in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYX
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYX
1in 2022
MAUDE reports naming product code IYX, 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 | 2 | — | 0 | 11 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 2 | — | 0 | 8 |
| 2010 | 4 | 82 | 0 | 5 |
| 2011 | 3 | 82 | 0 | 6 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 2 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ProxiScan" is indicated for use in imaging the distribution of radionuclides in the human body using planar imaging techniques. ProxiScan~ may also be used intraoperatively, on pathological specimens and for endocavity applications if a protective sheath is used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093706 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093706: Proxiscan Model 101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093706
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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