IYX · Camera, Scintillation (Gamma)
Radiology · 21 CFR 892.1100 · Class 1
Overview
| Product Code | IYX |
|---|---|
| Device Name | Camera, Scintillation (Gamma) |
| Regulation | 21 CFR 892.1100 |
| Device Class | Class 1 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.
Classification Rationale
Class I (general controls).
Recent Cleared Devices (20 of 130)
Showing 20 most recent of 130 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K230221 | QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) | Versant Medical Physics and Radiation Safety | Aug 28, 2023 | SESE |
| K212587 | 3D-RD-S | Radiopharmaceutical Imaging and Dosimetry, LLC | Feb 22, 2023 | SESE |
| K163687 | OLINDA EXM | Hermes Medical Solutions AB | Jul 19, 2017 | SESE |
| K160933 | Discovery NM 750b Bopsy | GE Healthcare | Nov 18, 2016 | SESE |
| K162052 | Sentinella 102, Sentinella 102 Horus | General Equipment For Medical Imaging (Oncovision- | Aug 18, 2016 | SESE |
| K143156 | Sentinella 102; Sentinella 102 Horus | General Equipment For Medical Imaging (Oncovision- | Nov 18, 2014 | SESE |
| K123408 | ERGO IMAGING SYSTEM | Digirad Corp. | Jan 15, 2013 | SESE |
| K111791 | LUMAGEM MOLECULAR BREAST IMAGING SYSTEM | Gamma Medica-Ideas Incorporated | Sep 23, 2011 | SESE |
| K110384 | DILON 6800 ACELLA (ACELLA) | Dilon Technologies, Inc. | May 3, 2011 | SESE |
| K110601 | SENTINELLA 102 | General Equipment For Medical Imaging, S.A. | Mar 18, 2011 | SESE |
| K102231 | DISCOVERY NM 750B | Ge Medical Systems Israel, Functional Imaging | Nov 3, 2010 | SESE |
| K101391 | SCANDIA-45 GAMMA CAMERA SYSTEM | Scandia Corporation | Aug 4, 2010 | SESE |
| K100838 | ERGO IMAGING SYSTEM | Digirad Corp. | Apr 23, 2010 | SESE |
| K093706 | PROXISCAN MODEL 101 | Hybridyne Imaging Technologies, Inc. | Apr 2, 2010 | SESE |
| K082588 | GAMMALOC SYSTEM, MODEL 03-00001 | Dilon Technologies, LLC | Dec 11, 2009 | SESE |
| K092471 | MODEL SENTINELLA 102 | General Equipment For Medical Imaging, S.A. | Oct 2, 2009 | SESE |
| K081757 | VERISTA IMAGING ISOCAM II GAMMA CAMERA | Verista Imaging, Inc. | Aug 15, 2008 | SESE |
| K081829 | CAPIMAGE | Danish Diagnostic Development A/S | Jul 11, 2008 | SESE |
| K073456 | T-QUEST SYSTEM | Medx, Inc. | Dec 20, 2007 | SESE |
| K071195 | KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5 | Ani-Kal Ii, LLC | Jun 20, 2007 | SESE |
Top Applicants
- General Electric Co. — 15 clearances
- Siemens Gammasonics, Inc. — 11 clearances
- Adac Laboratories — 6 clearances
- Toshiba Medical Systems — 5 clearances
- Medtronic Vascular — 5 clearances
