510(k) · Cleared
ClearedDeclipsespect Viewer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgiceye GmbH · IZD Probe, Uptake, Nuclear
Cleared on Jan 25, 2013 after a 37-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 25, 2013
- Review
- 37 days
- Class
- Class I
- Product code
- IZD
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IZD? 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’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All IZD devicesIZD Probe, Uptake, Nuclear: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · IZD
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · IZD
Too few IZD 510(k)s in any year since 2007 to give a median.
Recalls per year · IZD
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZD
8in 2025
MAUDE reports naming product code IZD, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 2 | 4 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
declipseSPECT Viwer works in conjuncion with a nuclear uptake detector capable of measuring the amount of radionuclide taken up by a particular organ or body region, dedipseSPECT Viewer is intended to use the said detector and generate images of the distnibution of radionuclides in the human body and determine the 3D localization of these radioniuclides relative to surgical instruments by means of tracking technologies and image reconstruction…
Read the full statement (325 words)
declipseSPECT Viwer works in conjuncion with a nuclear uptake detector capable of measuring the amount of radionuclide taken up by a particular organ or body region, dedipseSPECT Viewer is intended to use the said detector and generate images of the distnibution of radionuclides in the human body and determine the 3D localization of these radioniuclides relative to surgical instruments by means of tracking technologies and image reconstruction techtniques. The declipseSPECT Viewer is also intended to be used for hybrid nuclear medicine image viewing i-situ, such as SPECTICT and PET/CT_
declipseSPECT Viewer may also be used intraciperativelly or on pathological specimens if a protective cover is used to cover the nuclear uptake detector dedipseSPECT Viewer may be used at the patienit's bedside, or in an Emergency Room or Intensive Care Unit The scan and operation of the system can be performed by medical staff, including technicians, nurses, physicist anid physicians that ame trained to use the system. The generated images can be used also for documentation and reporting. The interpretation and use of the images generated is intended to be done by trained personnel.
declipseSPECT Viwr is compatible crrently tofdoMgncear upte detec.s
Probe Manufacturer: Crystal Photonics; Probe Model: S003; Probe Model/Energy range of gamma rays: Gamma Probe CXS-OP-SZBN, 70 -245 key
Probe Manufacturer: Crystal Photonics; Probe Model: S004; Probe Model/Energy range of gamma rays: Gamma Probe, CXS-OP-SP, 70 -245 keV
Probe Manufacturer: Crystal Photonics; Probe Model: Beta; Probe Model/Energy range of gamma rays: Probe, CXS-OP-SB, 27 -30 keV
Probe Manufacturer: RMD; Probe Model: Navigator; Probe Model/Energy range of gamma rays: Gamma Probe;, SP2A14, 27 -245 keV
Probe Manufacturer: RMD; Probe Model: GPS; Probe Model/Energy range of gamma rays: curved; Gamma Probe;, SP2514, 27 - 245 key
Probe Manufacturer: RMD; Probe Model: GPS; Probe Model/Energy range of gamma rays: straight; Gamma Probe;, SP2514, 27 - 245 key
Probe Manufacturer: Eurorad; Probe Model: Europrobe 3; Probe Model/Energy range of gamma rays: Gamma Probe SOE31, 27 - 245 key
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K123917 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123917: Declipsespect Viewer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123917
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026