510(k) K092471
- Device
- MODEL SENTINELLA 102
- Applicant
- GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A
- 510(k) number
- K092471
- Product code
- IYX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-10-02
- Date received
- 2009-08-11
- Regulation
- 892.1100
- Classification name
- Camera, Scintillation (gamma)
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- SEVERINE MOINE
- Address
- Camino De Vera S/N Edificio 9b Valencia ES 46022 46022
FDA Registration Numbers#
- 3002807315
- 2132111
- 3014954414
- 9613299
- 2433682
- 3023006704
- 3004363352
- 3006611212
- 3009470597
- 2031050
- 3005496266
- 3017754782
- 1423348
- 3015232217
- 3005945241
- 9710645
- 3005128583
- 3008962177
- 3027338963
- 3030186509
- 2020678
Source Documents#
Other 510(k) Records For Product Code IYX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230221 | QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) | Versant Medical Physics and Radiation Safety | 2023-08-28 |
| K212587 | 3D-RD-S | Radiopharmaceutical Imaging and Dosimetry, LLC | 2023-02-22 |
| K163687 | OLINDA EXM | Hermes Medical Solutions AB | 2017-07-19 |
| K160933 | Discovery NM 750b Bopsy | GE Healthcare | 2016-11-18 |
| K162052 | Sentinella 102, Sentinella 102 Horus | General Equipment For Medical Imaging (Oncovision- | 2016-08-18 |
| K143156 | Sentinella 102; Sentinella 102 Horus | General Equipment For Medical Imaging (Oncovision- | 2014-11-18 |
| K123408 | ERGO IMAGING SYSTEM | Digirad Corp. | 2013-01-15 |
| K111791 | LUMAGEM MOLECULAR BREAST IMAGING SYSTEM | Gamma Medica-Ideas Incorporated | 2011-09-23 |
| K110384 | DILON 6800 ACELLA (ACELLA) | Dilon Technologies, Inc. | 2011-05-03 |
| K110601 | SENTINELLA 102 | General Equipment For Medical Imaging, S.A. | 2011-03-18 |
| K102231 | DISCOVERY NM 750B | Ge Medical Systems Israel, Functional Imaging | 2010-11-03 |
| K101391 | SCANDIA-45 GAMMA CAMERA SYSTEM | Scandia Corporation | 2010-08-04 |
| K100838 | ERGO IMAGING SYSTEM | Digirad Corp. | 2010-04-23 |
| K093706 | PROXISCAN MODEL 101 | Hybridyne Imaging Technologies, Inc. | 2010-04-02 |
| K082588 | GAMMALOC SYSTEM, MODEL 03-00001 | Dilon Technologies, LLC | 2009-12-11 |
Legacy Summary#
summary
FDA Review#
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