510(k) · Cleared
Recalled · 2004Onepass Nuclear Imaging System, Model 70-500101
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gvi Technology Partners · IYX Camera, Scintillation (Gamma)
Cleared on Jan 3, 2003 as substantially equivalent to K931193 (Scinticor, Inc., 1993) after an 87-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it. It has been recalled once.
- Decided
- Jan 3, 2003
- Review
- 87 days
- Class
- Class I
- Product code
- IYX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K931193 (1993). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK931193 Sim-400 SystemScinticor, Inc. · 1993
- This deviceK023373 Onepass Nuclear Imaging System, Model 70-500101Gvi Technology Partners · 2003
- Descendant · cites it directly · 0 of its ownK072191 Clearvision Nuclear Medicine Imaging SystemGvi Technology Partners · 2007
- Descendant · cites it directly · 0 of its ownK051402 Onepass Nuclear Medicine Imaging SystemGvi Technology Partners · 2005
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931193 | Sim-400 System | Scinticor, Inc. | 1993 | — |
| 0 (this device) | K023373 | Onepass Nuclear Imaging System, Model 70-500101 | Gvi Technology Partners | 2003 | — |
| +1 | K072191 | Clearvision Nuclear Medicine Imaging System | Gvi Technology Partners | 2007 | — |
| +1 | K051402 | Onepass Nuclear Medicine Imaging System | Gvi Technology Partners | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 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? (1)
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 |
|---|---|---|---|
| * | K931193 | Sim-400 SystemSummary page 1…ation Name: Camera, Scintillation (Gamma) Reason for 51O( k) Submission New Device Predicate Device SIM-400 System, Scinticor, Inc. 510(k) Number: K931193 Device Description The OnePass Nuclear Medicine Imaging Systems acquires and processes gated First Pass Radionuclide Angiography… | 1993 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 16, 2004 | Not classified | Z-0527-04 | Other | Due to limitations in the operating software, the acquired scan may not be processed properly. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K072191 (Gvi Technology Partners, 2007) has gone furthest, with 0 descendants of its own.
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 OnePass nuclear medicine imaging system is intended for use as a diagnostic imaging device Used with appropriate radiopharmaceuticals, it produces images that depict the anatomical distribution of radioisotopes within the human body. The OnePass system's compact lfootprint and small FOV detector are specifically designed for placement in a facility lacking adequate flooi space for a typical nuclear medicine imaging system.
The OnePass system's design is optimized for acquiring and processing cardiac first pass data. First-pass radionuclide angiography (FPRNA) is used to assess left and right ventricular function at rest or during stress.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023373 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023373: Onepass Nuclear Imaging System, Model 70-500101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023373
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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