Ergo Imaging System
FDA 510(k) K100838 · Digirad Corp.
510(k) numberK100838
Submission
- Device name
- Ergo Imaging System
- Applicant
- Digirad Corp.
Poway, CA, US - Received
- March 24, 2010
- Decision date
- April 23, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IYX
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| K143156 | Sentinella 102; Sentinella 102 HorusIYX · Traditional | General Equipment For Medical Imaging (Oncovision- | 11/18/2014SE |
| K123408 | Ergo Imaging SystemIYX · Traditional | Digirad Corp. | 01/15/2013SE |
| K111791 | Lumagem Molecular Breast Imaging SystemIYX · Traditional | Gamma Medica-Ideas Incorporated | 09/23/2011SE |
| K110384 | Dilon 6800 Acella (Acella)IYX · Traditional | Dilon Technologies, Inc. | 05/03/2011SE |
| K110601 | Sentinella 102IYX · Traditional | General Equipment For Medical Imaging, S.A. | 03/18/2011SE |
More from General Equipment For Medical Imaging, S.A.
| 510(k) | Device | Decision |
|---|---|---|
| K123408 | Ergo Imaging SystemIYX · Traditional | 01/15/2013SE |
| 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 |
| K023110 | Cedars-Sinai Motion Correction (Moco) Software, Model 111005KPS · Traditional | 11/22/2002SE |
| K011572 | Quantitative Gated SPECT (QGS), Quantitative Perfusion SPECT (QPS)KPS · Traditional | 06/15/2001SE |
Questions and answers
When was Ergo Imaging System cleared by the FDA?
Ergo Imaging System (K100838) received a 510(k) decision of Substantially Equivalent on April 23, 2010, 30 days after the submission was received.
What is the product code of K100838?
The FDA product code is IYX – Camera, Scintillation (Gamma), a Class I (low risk) device regulated under 21 CFR 892.1100.