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US
Last updated May 23, 2026
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Catalogue (32)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Cardius 2 | XPOD International | FDA UDI | Class II | Active |
| Cardius 3 | Mobile XPOD | FDA UDI | Class II | Active |
| Cardius X-Act | International | FDA UDI | Class II | Active |
| Breast Imaging Accessory | BIA | FDA UDI | Class I | Active |
| Cardius 2 | Mobile XPOL | FDA UDI | Class II | Active |
| Cardius 2 | Mobile XPOD | FDA UDI | Class II | Active |
| Cardius X-Act | Domestic | FDA UDI | Class II | Active |
| Diverging Collimator | Diverging | FDA UDI | Class I | Active |
| LEAP Collimator | LEAP | FDA UDI | Class I | Active |
| Cardius 3 | XPOD | FDA UDI | Class II | Active |
| MEAP Collimator | MEAP | FDA UDI | Class I | Active |
| Cardius 2 | XPOD | FDA UDI | Class II | Active |
| Mamo Collimator | Mamo | FDA UDI | Class I | Active |
| Cardius 1 | Mobile | FDA UDI | Class II | Active |
| LEHR Collimator | LEHR | FDA UDI | Class I | Active |
| PINHOLE Collimator | PINHOLE | FDA UDI | Class I | Active |
| Cardius 1, 2 And 3 Xpo And 2020tc Spect Imaging Systems | K070542 | FDA 510(k) | Class II | Active |
| Cardius-1, Cardius-2, Cardius-3, 2020tc Spect Imaging System | K051549 | FDA 510(k) | Class II | Active |
| Cardius-1, Cardius-2, Cardius-3, 2020tc Spect Imaging System | K052430 | FDA 510(k) | Class II | Active |
| Quantitative Gated Spect (qgs), Quantitative Perfusion Spect (qps) | K011572 | FDA 510(k) | Class II | Active |
| Cardius-1, -2, -3, And Cardius 1, 2, 3 Xpo Spect Imaging Systems, 2020tc Spect Imaging System | K082368 | FDA 510(k) | Class II | Active |
| Cedars-Sinai Motion Correction (moco) Software, Model 111005 | K023110 | FDA 510(k) | Class II | Active |
| Cardius-1 And Cardis-2 | K030085 | FDA 510(k) | Class II | Active |
| Digirad 2020tc Spect Imaging System | K982855 | FDA 510(k) | Class II | Active |
| Digirad Reusable Image Media | K854407 | FDA 510(k) | Class I | Active |
| Ergo Imaging System | K123408 | FDA 510(k) | Class I | Active |
| Cardius 3 X-Act | K083649 | FDA 510(k) | Class II | Active |
| Digirad Cfr 2000 Radiographic Film Cassette | K828562 | FDA 510(k) | N/A | Active |
| Digirad System 1 And The Reusuable Image Media | K852284 | FDA 510(k) | Class II | Active |
| Ergo Imaging System | K100838 | FDA 510(k) | Class I | Active |
| Notebook Imager | K961104 | FDA 510(k) | Class I | Active |
| Stasys Motion Correction Software | K082904 | FDA 510(k) | Class II | Active |
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