Cedars-Sinai Motion Correction (Moco) Software, Model 111005
FDA 510(k) K023110 · Digirad Corp.
510(k) numberK023110
Submission
- Device name
- Cedars-Sinai Motion Correction (Moco) Software, Model 111005
- Applicant
- Digirad Corp.
San Diego, CA, US - Received
- September 19, 2002
- Decision date
- November 22, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K253844 | AnyScan 3.0 NM Scanner FamilyKPS · Traditional | Mediso Medical Imaging Systems, Ltd. | 12/30/2025SE |
| K251370 | Cartesion Prime (PCD-1000A/3) V10.21KPS · Traditional | Canon Medical Systems Corporation | 12/01/2025SE |
| K251401 | PennPET Explorer Positron Emission TomographKPS · Traditional | Trustees of the University of Pennsylvania | 11/25/2025SE |
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More from Hermes Medical Solutions AB
| 510(k) | Device | Decision |
|---|---|---|
| K123408 | Ergo Imaging SystemIYX · Traditional | 01/15/2013SE |
| K100838 | Ergo Imaging SystemIYX · Special | 04/23/2010SE |
| K083649 | Cardius 3 X-ActKPS · Traditional | 03/09/2009SE |
| K082904 | Stasys Motion Correction SoftwareKPS · Traditional | 12/17/2008SE |
| K082368 | CARDIUS-1, -2, -3, and Cardius 1,2,3 Xpo SPECT Imaging Systems, 2020TC SPECT Imaging…KPS · Special | 09/12/2008SE |
| K070542 | Cardius 1, 2 and 3 Xpo and 2020TC SPECT Imaging SystemsKPS · Special | 03/23/2007SE |
| K052430 | CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT Imaging SystemKPS · Special | 10/04/2005SE |
| K051549 | CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT Imaging SystemKPS · Special | 07/13/2005SE |
| K030085 | CARDIUS-1 and CARDIS-2KPS · Special | 02/05/2003SE |
| K011572 | Quantitative Gated SPECT (QGS), Quantitative Perfusion SPECT (QPS)KPS · Traditional | 06/15/2001SE |
Questions and answers
When was Cedars-Sinai Motion Correction (Moco) Software, Model 111005 cleared by the FDA?
Cedars-Sinai Motion Correction (Moco) Software, Model 111005 (K023110) received a 510(k) decision of Substantially Equivalent on November 22, 2002, 64 days after the submission was received.
What is the product code of K023110?
The FDA product code is KPS – System, Tomography, Computed, Emission, a Class II (moderate risk) device regulated under 21 CFR 892.1200.