510(k) · Cleared
ClearedEZ-Scope an & EZ-Scope an Lite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Health Policy Resorters Group, LLC · IYX Camera, Scintillation (Gamma)
Cleared on May 28, 2002 as substantially equivalent to K961104 (Digirad Corp., 1997) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1989. 3 later devices descend from it.
- Decided
- May 28, 2002
- Review
- 90 days
- Class
- Class I
- Product code
- IYX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K885054 (1989). 7 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK885054 System Seventy SevenScinticor, Inc. · 1989
- 1 generation backK961104 Notebook ImagerDigirad Corp. · 1997
- This deviceK020643 EZ-Scope an & EZ-Scope an LiteHealth Policy Resorters Group, LLC · 2002
- Descendant · cites it directly · 2 of its ownK022342 EZ-Scope an, EZ-Scope LightAnzai Medical Co., Ltd. · 2002
- Descendant · 2 generations on · 0 of its ownK093706 Proxiscan Model 101Hybridyne Imaging Technologies, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK092471 Model Sentinella 102General Equipment For Medical Imaging, S.A. · 2009
Most influential descendants
Showing 3 of 3 · See all- K022342EZ-Scope an, EZ-Scope LightAnzai Medical Co., Ltd. · 2002 · cites it directly2descendants
- K093706Proxiscan Model 101Hybridyne Imaging Technologies, Inc. · 2010 · 2 generations on0descendants
- K092471Model Sentinella 102General Equipment For Medical Imaging, S.A. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K885054 | System Seventy Seven | Scinticor, Inc. | 1989 | — |
| −1 | K961104 | Notebook Imager | Digirad Corp. | 1997 | — |
| 0 (this device) | K020643 | EZ-Scope an & EZ-Scope an Lite | Health Policy Resorters Group, LLC | 2002 | — |
| +1 | K022342 | EZ-Scope an, EZ-Scope Light | Anzai Medical Co., Ltd. | 2002 | — |
| +2 | K093706 | Proxiscan Model 101 | Hybridyne Imaging Technologies, Inc. | 2010 | — |
| +2 | K092471 | Model Sentinella 102 | General Equipment For Medical Imaging, S.A. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K961104 | Notebook Imager Our OCR of the scanned summary read K961004, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Notebook Imager”. | 1997 |
| * | K992731 | E.Cam ComputerSummary page 1…er made by Digirad, which was cleared by FDA on May 28, 1997 as K961004. For some characteristics, it is also substantially equivalent to the Siemens E.CAM gamma camera (K992731) and the Neoprobe 2000 Isotope Probe (based on K971320 for the Neo 1500). B. DEVICE DESCRIPTION The Anzai eZ-Scope AN Portable… | 1999 |
| Kept off the family tree | K971320 | FDA’s K971320 is Cre Balloon Dilatation Catheter Our OCR of the scanned summary read K971320, FDA’s number for Cre Balloon Dilatation Catheter (Boston Scientific Corp). Its FDA name has none of the distinctive words the summary uses for the device it names, “Neoprobe 2000 Isotope Probe”. Kept off the family tree. Summary page 1…1997 as K961004. For some characteristics, it is also substantially equivalent to the Siemens E.CAM gamma camera (K992731) and the Neoprobe 2000 Isotope Probe (based on K971320 for the Neo 1500). B. DEVICE DESCRIPTION The Anzai eZ-Scope AN Portable Gamma Camera is a new and innovative portable gamma cam… | 1997 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022342 | EZ-Scope an, EZ-Scope Light | 2002 | 2 |
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 13 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K022342 (Anzai Medical Co., Ltd., 2002) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K961104.
How does its category compare?
All IYX devicesIYX Camera, Scintillation (Gamma): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Anzai eZ-Scope AN Portable Gamma Camera is indicated for use to image the distribution of radionuclides in the human body using planar imaging techniques. The eZ-Scope may be used on pathological specimens if a protective sheath is used.
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/K020643 · printed Nov 3, 2026
Cite this page
510(k) Report. “K020643: EZ-Scope an & EZ-Scope an Lite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K020643
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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