Product code IYX
- Device name
- Camera, Scintillation (Gamma)
- Medical specialty
- Radiology
- Device class
- 1
- Regulation number
- 892.1100
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 |
| K092471 | MODEL SENTINELLA 102 | General Equipment For Medical Imaging, S.A. | 2009-10-02 |
| K081757 | VERISTA IMAGING ISOCAM II GAMMA CAMERA | Verista Imaging, Inc. | 2008-08-15 |
| K081829 | CAPIMAGE | Danish Diagnostic Development A/S | 2008-07-11 |
| K073456 | T-QUEST SYSTEM | Medx, Inc. | 2007-12-20 |
| K071195 | KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5 | Ani-Kal Ii, LLC | 2007-06-20 |
| K062141 | MAMMOPAD RADIOLUCENT CUSHION | Biolucent, Inc. | 2006-09-13 |
| K052473 | CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000 | Inter Medical Medizintechnik GmbH | 2005-10-28 |
| K051402 | ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM | Gvi Technology Partners | 2005-06-13 |
| K033960 | OLINDA/EXM | Vanderbilt University | 2004-06-15 |
| K040587 | MINI GAMMA CAMERA, MODEL MGC-500 | Acrorad Co., Ltd. | 2004-05-14 |
| K023373 | ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101 | Gvi Technology Partners | 2003-01-03 |
| K022342 | EZ-SCOPE AN, EZ-SCOPE LIGHT | Anzai Medical Co., Ltd. | 2002-10-09 |
| K020643 | EZ-SCOPE AN & EZ-SCOPE AN LITE | Health Policy Resorters Group, LLC | 2002-05-28 |
| K003775 | PORTABLE BREAST COMPRESSION DEVICE | Pem Technologies | 2001-01-12 |
| K993813 | LUMAGEM SCINTILLATION CAMERA | Gamma Medica | 2000-01-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00859873006219 | Hermia OLINDA | Hermes Medical Solutions AB | 2026-03-10 |
| 00810149098215 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2025-12-15 |
| 00810149098116 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2025-10-15 |
| B843UNISYN7510 | UniSyn | Convergent Imaging Solutions Incorporated | 2025-08-20 |
| 00810149098000 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2025-07-14 |
| 00810149097966 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2025-05-22 |
| 00810149097928 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2025-03-04 |
| 00810149097799 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2025-02-13 |
| 00810149097836 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2025-02-13 |
| 00810149097843 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2025-02-13 |
| 00810149097737 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2025-01-29 |
| 00810149097713 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2025-01-14 |
| 00810149097706 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2025-01-07 |
| 00810149097683 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2024-12-13 |
| 00810149097690 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2024-12-13 |
| 00810149097638 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2024-11-05 |
| 00810149097621 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2024-11-04 |
| 00810149097607 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2024-10-22 |
| 00810149097584 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2024-10-17 |
| 00810149097546 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2024-09-12 |
| 00810149097522 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2024-09-06 |
| 00810149097409 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2024-08-09 |
| 00810149097287 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2024-06-18 |
| 00810149097270 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2024-04-15 |
| 00810149097263 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2024-03-05 |
| 00810149090141 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2024-01-01 |
| 00810149090073 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2024-01-01 |
| 06973211070640 | Ophthalmic Ultrasound Examination Instrument | CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD | 2023-01-17 |
| 06973211070701 | Ophthalmic Ultrasound Examination Instrument | CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD | 2023-01-17 |
| 06945868601874 | Sonoscape | SONOSCAPE MEDICAL CORP. | 2017-09-14 |