510(k) · Cleared
ClearedCapimage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Danish Diagnostic Development A/S · IYX Camera, Scintillation (Gamma)
Cleared on Jul 11, 2008 as substantially equivalent to K011611 (Danish Diagnostic Development A/S, 2001) after a 14-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Jul 11, 2008
- Review
- 14 days
- Class
- Class I
- Product code
- IYX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011611 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK011611 Cardiocam Model 9CSY0799Danish Diagnostic Development A/S · 2001 · Recalled
- This deviceK081829 CapimageDanish Diagnostic Development A/S · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011611 | Cardiocam Model 9CSY0799 | Danish Diagnostic Development A/S | 2001 | 1 |
| 0 (this device) | K081829 | Capimage | Danish Diagnostic Development A/S | 2008 | — |
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 |
|---|---|---|---|
| * | K011611 | Cardiocam Model 9CSY0799Summary page 1…te device: Device Trade Name: CardioMD (initially Cardiocam). Product code: 90-KPS 510(K): K011611 Side 1of 5 4. Device Description. The CapIMAGE is a mobile Small… | 2001 |
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?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K011611.
How does its category compare?
All IYX devicesIYX Camera, Scintillation (Gamma): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 CapIMAGE Gamma Camera System is intended to produce planar images depicting the
anatomical distributions of single photon emitting radioisotopes in the human body within the energy
range of 59kev to 167kev. The system provides software applications for processing, analyzing, and
displaying medical images for interpretation by medical personnel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081829 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081829: Capimage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081829
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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