ERGO IMAGING SYSTEM
FDA 510(k) clearance K100838 · decided 2010-04-23
Clearance details
- K-number
- K100838
- Device name
- ERGO IMAGING SYSTEM
- Applicant
- Digirad Corp.
- Decision
- Substantially Equivalent
- Date received
- 2010-03-24
- Decision date
- 2010-04-23
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- IYX
- Device class
- 1
- Regulation number
- 892.1100
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Poway, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
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| 3D-RD-S (K212587) | Radiopharmaceutical Imaging and Dosimetry, LLC | 2023-02-22 |
| OLINDA EXM (K163687) | Hermes Medical Solutions AB | 2017-07-19 |
| Discovery NM 750b Bopsy (K160933) | GE Healthcare | 2016-11-18 |
| Sentinella 102, Sentinella 102 Horus (K162052) | General Equipment For Medical Imaging (Oncovision- | 2016-08-18 |
| Sentinella 102; Sentinella 102 Horus (K143156) | General Equipment For Medical Imaging (Oncovision- | 2014-11-18 |
| ERGO IMAGING SYSTEM (K123408) | Digirad Corp. | 2013-01-15 |
| LUMAGEM MOLECULAR BREAST IMAGING SYSTEM (K111791) | Gamma Medica-Ideas Incorporated | 2011-09-23 |
| DILON 6800 ACELLA (ACELLA) (K110384) | Dilon Technologies, Inc. | 2011-05-03 |
| SENTINELLA 102 (K110601) | General Equipment For Medical Imaging, S.A. | 2011-03-18 |
| DISCOVERY NM 750B (K102231) | Ge Medical Systems Israel, Functional Imaging | 2010-11-03 |
| SCANDIA-45 GAMMA CAMERA SYSTEM (K101391) | Scandia Corporation | 2010-08-04 |
Recalls involving this device
No recalls on record reference this clearance.