Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IYX — Predicate Candidate Screening
130 FDA 510(k) clearances under this product code; the 50 most recent screened below.
71 daysmedian FDA review time
197 days90th percentile
130clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230221 | QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry | Versant Medical Physics and Radiation Safety | 2023-08-28 | 214 | 0 |
| K212587 | 3D-RD-S | Radiopharmaceutical Imaging and Dosimetry, LLC | 2023-02-22 | 555 | 0 |
| K163687 | OLINDA EXM | Hermes Medical Solutions AB | 2017-07-19 | 203 | 0 |
| K160933 | Discovery NM 750b Bopsy | GE Healthcare | 2016-11-18 | 228 | 0 |
| K162052 | Sentinella 102, Sentinella 102 Horus | General Equipment For Medical Imaging (Oncovision- | 2016-08-18 | 24 | 0 |
| K143156 | Sentinella 102; Sentinella 102 Horus | General Equipment For Medical Imaging (Oncovision- | 2014-11-18 | 15 | 0 |
| K123408 | ERGO IMAGING SYSTEM | Digirad Corp. | 2013-01-15 | 71 | 0 |
| K111791 | LUMAGEM MOLECULAR BREAST IMAGING SYSTEM | Gamma Medica-Ideas Incorporated | 2011-09-23 | 88 | 0 |
| K110384 | DILON 6800 ACELLA (ACELLA) | Dilon Technologies, Inc. | 2011-05-03 | 82 | 0 |
| K110601 | SENTINELLA 102 | General Equipment For Medical Imaging, S.A. | 2011-03-18 | 16 | 0 |
| K102231 | DISCOVERY NM 750B | Ge Medical Systems Israel, Functional Imaging | 2010-11-03 | 86 | 0 |
| K101391 | SCANDIA-45 GAMMA CAMERA SYSTEM | Scandia Corporation | 2010-08-04 | 78 | 0 |
| K100838 | ERGO IMAGING SYSTEM | Digirad Corp. | 2010-04-23 | 30 | 0 |
| K093706 | PROXISCAN MODEL 101 | Hybridyne Imaging Technologies, Inc. | 2010-04-02 | 122 | 0 |
| K082588 | GAMMALOC SYSTEM, MODEL 03-00001 | Dilon Technologies, LLC | 2009-12-11 | 459 | 0 |
| K092471 | MODEL SENTINELLA 102 | General Equipment For Medical Imaging, S.A. | 2009-10-02 | 52 | 0 |
| K081757 | VERISTA IMAGING ISOCAM II GAMMA CAMERA | Verista Imaging, Inc. | 2008-08-15 | 56 | 0 |
| K081829 | CAPIMAGE | Danish Diagnostic Development A/S | 2008-07-11 | 14 | 0 |
| K073456 | T-QUEST SYSTEM | Medx, Inc. | 2007-12-20 | 10 | 0 |
| K071195 | KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION | Ani-Kal Ii, LLC | 2007-06-20 | 51 | 0 |
| K062141 | MAMMOPAD RADIOLUCENT CUSHION | Biolucent, Inc. | 2006-09-13 | 48 | 0 |
| K052473 | CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000 | Inter Medical Medizintechnik GmbH | 2005-10-28 | 49 | 0 |
| K051402 | ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM | Gvi Technology Partners | 2005-06-13 | 13 | 0 |
| K033960 | OLINDA/EXM | Vanderbilt University | 2004-06-15 | 176 | 0 |
| K040587 | MINI GAMMA CAMERA, MODEL MGC-500 | Acrorad Co., Ltd. | 2004-05-14 | 70 | 0 |
| K023373 | ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101 | Gvi Technology Partners | 2003-01-03 | 87 | 1 |
| K022342 | EZ-SCOPE AN, EZ-SCOPE LIGHT | Anzai Medical Co., Ltd. | 2002-10-09 | 83 | 0 |
| K020643 | EZ-SCOPE AN & EZ-SCOPE AN LITE | Health Policy Resorters Group, LLC | 2002-05-28 | 90 | 0 |
| K003775 | PORTABLE BREAST COMPRESSION DEVICE | Pem Technologies | 2001-01-12 | 37 | 0 |
| K993813 | LUMAGEM SCINTILLATION CAMERA | Gamma Medica | 2000-01-18 | 69 | 0 |
| K984466 | DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5 | Dilon Technologies, Inc. | 1999-03-16 | 90 | 0 |
| K961104 | NOTEBOOK IMAGER | Digirad Corp. | 1997-05-28 | 434 | 0 |
| K945792 | IM512P | Globus Industries | 1995-05-24 | 180 | 0 |
| K943602 | DI-2000 | Miles Inc., Agfa Division | 1995-05-12 | 291 | 0 |
| K935273 | VISION FX 40 & 80 SERIES GAMMA CAMERA | Summit Nuclear | 1994-04-18 | 167 | 2 |
| K932701 | CEDARS-SINAI QUANTITIVE THALLIUM 201 ANALYSIS | Nuccardiac Software, Inc. | 1994-03-29 | 299 | 0 |
| K932673 | APEX SPX CARDIAL | Elscint, Inc. | 1994-02-18 | 261 | 1 |
| K934766 | CARBON FIBER PALLET | Siemens Gammasonics, Inc. | 1994-02-18 | 137 | 0 |
| K933513 | R &D BATTERIES, INC. PART # 5015, 5192, 5482 | R & D Batteries, Inc. | 1993-11-24 | 127 | 0 |
| K933256 | FAN BEAM COLLIMATOR | Siemens Gammasonics, Inc. | 1993-10-29 | 115 | 0 |
| K932957 | QUANTEM (TM) | GE Medical Systems | 1993-08-05 | 49 | 0 |
| K923180 | SPECTURN, MODEL TTK-128 | Harpell Assoc., Inc. | 1993-07-26 | 391 | 0 |
| K930283 | THYRUS | Adac Laboratories | 1993-06-21 | 151 | 0 |
| K926550 | UNIX-LINK | General Electric Co. | 1993-03-18 | 77 | 0 |
| K926083 | NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES | Biodan Medical Systems, Ltd. | 1993-02-12 | 73 | 0 |
| K924878 | NEW DETECTOR OPTION | Adac Laboratories | 1993-01-15 | 136 | 0 |
| K924639 | NEW DETECTOR FOR TRANSCAM/POLARIS S315 | Adac Laboratories | 1993-01-15 | 135 | 0 |
| K923356 | MEDX ROTATIONAL GANTRY SYSTEM | Bfi- Medical Waste Systems | 1992-09-21 | 75 | 0 |
| K921296 | ADAC S315 | Adac Laboratories | 1992-05-28 | 72 | 0 |
| K910967 | NEUROCAM | GE Medical Systems | 1991-07-03 | 119 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda