Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1100](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1100) → IYX — Camera, Scintillation (Gamma) # IYX · Camera, Scintillation (Gamma) _Radiology · 21 CFR 892.1100 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX ## Overview - **Product Code:** IYX - **Device Name:** Camera, Scintillation (Gamma) - **Regulation:** [21 CFR 892.1100](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1100) - **Device Class:** 1 - **Review Panel:** [Radiology](/submissions/RA) - **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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX/K230221.md) | QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) | Versant Medical Physics and Radiation Safety | Aug 28, 2023 | SESE | | [K212587](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX/K212587.md) | 3D-RD-S | Radiopharmaceutical Imaging and Dosimetry, LLC | Feb 22, 2023 | SESE | | [K163687](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX/K163687.md) | OLINDA EXM | Hermes Medical Solutions AB | Jul 19, 2017 | SESE | | [K160933](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX/K160933.md) | Discovery NM 750b Bopsy | GE Healthcare | Nov 18, 2016 | SESE | | [K162052](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX/K162052.md) | Sentinella 102, Sentinella 102 Horus | General Equipment For Medical Imaging (Oncovision- | Aug 18, 2016 | SESE | | [K143156](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX/K143156.md) | Sentinella 102; Sentinella 102 Horus | General Equipment For Medical Imaging (Oncovision- | Nov 18, 2014 | SESE | | [K123408](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX/K123408.md) | ERGO IMAGING SYSTEM | Digirad Corp. | Jan 15, 2013 | SESE | | [K111791](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX/K111791.md) | LUMAGEM MOLECULAR BREAST IMAGING SYSTEM | Gamma Medica-Ideas Incorporated | Sep 23, 2011 | SESE | | [K110384](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX/K110384.md) | DILON 6800 ACELLA (ACELLA) | Dilon Technologies, Inc. | May 3, 2011 | SESE | | [K110601](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX/K110601.md) | SENTINELLA 102 | General Equipment For Medical Imaging, S.A. | Mar 18, 2011 | SESE | | [K102231](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX/K102231.md) | DISCOVERY NM 750B | Ge Medical Systems Israel, Functional Imaging | Nov 3, 2010 | SESE | | [K101391](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX/K101391.md) | SCANDIA-45 GAMMA CAMERA SYSTEM | Scandia Corporation | Aug 4, 2010 | SESE | | [K100838](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX/K100838.md) | ERGO IMAGING SYSTEM | Digirad Corp. | Apr 23, 2010 | SESE | | [K093706](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX/K093706.md) | PROXISCAN MODEL 101 | Hybridyne Imaging Technologies, Inc. | Apr 2, 2010 | SESE | | [K082588](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX/K082588.md) | GAMMALOC SYSTEM, MODEL 03-00001 | Dilon Technologies, LLC | Dec 11, 2009 | SESE | | [K092471](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX/K092471.md) | MODEL SENTINELLA 102 | General Equipment For Medical Imaging, S.A. | Oct 2, 2009 | SESE | | [K081757](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX/K081757.md) | VERISTA IMAGING ISOCAM II GAMMA CAMERA | Verista Imaging, Inc. | Aug 15, 2008 | SESE | | [K081829](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX/K081829.md) | CAPIMAGE | Danish Diagnostic Development A/S | Jul 11, 2008 | SESE | | [K073456](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX/K073456.md) | T-QUEST SYSTEM | Medx, Inc. | Dec 20, 2007 | SESE | | [K071195](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX/K071195.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com