510(k) · Cleared
ClearedModel Sentinella 102
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Equipment For Medical Imaging, S.A. · IYX Camera, Scintillation (Gamma)
Cleared on Oct 2, 2009 as substantially equivalent to K993813 (Gamma Medica, 2000) and 1 other predicate after a 52-day review. Its family tree reaches back 4 generations to 1989.
- Decided
- Oct 2, 2009
- Review
- 52 days
- Class
- Class I
- Product code
- IYX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K885054 (1989). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK885054 System Seventy SevenScinticor, Inc. · 1989
- 3 generations backK961104 Notebook ImagerDigirad Corp. · 1997
- 2 generations backK020643 EZ-Scope an & EZ-Scope an LiteHealth Policy Resorters Group, LLC · 2002
- 1 generation backK022342 EZ-Scope an, EZ-Scope LightAnzai Medical Co., Ltd. · 2002
- This deviceK092471 Model Sentinella 102General Equipment For Medical Imaging, S.A. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K885054 | System Seventy Seven | Scinticor, Inc. | 1989 | — |
| −3 | K961104 | Notebook Imager | Digirad Corp. | 1997 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
| 2000 | 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? (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 |
|---|---|---|---|
| * | K993813 | Lumagem Scintillation CameraSummary page 1…tion name: Scintillation Gamma Camera, Class I.21 CFR § 892.1100 (1990) Product: LumaGEM TM Scintillation Camera Manufacturer: Gamma Medica Instruments 510(k) number: K993813 Substantial Equivalence Date: 18/01/2000 Product: Anzai eZ-Scope AN Portable Gamma Camera Manufacturer: Anzai Medical Company, L… | 2000 |
| * | K022342 | EZ-Scope an, EZ-Scope LightSummary page 1…10(k) number: K993813 Substantial Equivalence Date: 18/01/2000 Product: Anzai eZ-Scope AN Portable Gamma Camera Manufacturer: Anzai Medical Company, Ltd. 510(k) number: K022342 Substantial Equivalence Date: 09/10/2002 Sentinella 102 is a portable gamma camera system including a small gamma camera desi… | 2002 |
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 20 years and passes through 5 companies; a new generation was cleared every 7.0 years on median.
- 3 of the 10 ancestors have a recall of any class.
- 2 other devices also cite its predicate K993813.
How does its category compare?
All IYX devicesIYX Camera, Scintillation (Gamma): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Sentinella 102 is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection. The images are intended to be interpreted by qualified personnel.
Sentinella 102 may be used intraoperatively if a protective sheath is used.
Sentinella 102 may be used at the patient's bedside, or in Emergency Room or Intensive Care Unit.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092471 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092471: Model Sentinella 102.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092471
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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