Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IZI — Predicate Candidate Screening
199 FDA 510(k) clearances under this product code; the 50 most recent screened below.
79 daysmedian FDA review time
229 days90th percentile
199clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261037 | 780 nm SPY Portable Handheld Imaging (SPY-PHI) System | Stryker Endoscopy | 2026-05-28 | 59 | 0 |
| K253181 | SURGIMAGE SIM 1000H Fluorescence Imaging Platform | Surgimage Corporation | 2026-05-13 | 229 | 0 |
| K243645 | IC-Flow™ Imaging System 2.0 | Diagnostic Green GmbH | 2025-09-22 | 300 | 0 |
| K243077 | Affirm 800 | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | 2025-06-27 | 270 | 0 |
| K231986 | Modus IR | Synaptive Medical, Inc. | 2024-03-25 | 264 | 0 |
| K234090 | EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile D | Surgvision GmbH | 2024-03-20 | 89 | 0 |
| K231075 | Fluorescence Accessories (YELLOW 560 and INFRARED 800 with F | Carl Zeiss Meditec, Inc. | 2023-06-20 | 67 | 0 |
| K230727 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc (A Part of Stryker) | 2023-06-05 | 81 | 0 |
| K222240 | EXPLORER AIR® II | Surgvision GmbH | 2023-02-28 | 217 | 0 |
| K214097 | Explorer Air II | Surgvision GmbH | 2022-02-25 | 59 | 0 |
| K202391 | DIR 800 | Aesculap, Inc. | 2021-01-21 | 153 | 0 |
| K192761 | Asimov-MKS Imaging System | Onlume, Inc. | 2020-01-17 | 109 | 0 |
| K190772 | SURGICAL MICROSCOPE SYSTEM ORBEYE with IR | Olympus Medical Systems Corp. | 2019-10-10 | 198 | 0 |
| K182907 | SPY Elite Intraoperative Perfusion Assessment System | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2019-01-23 | 98 | 0 |
| K181537 | GLOW800 | Leica Microsystems (Schweiz) AG | 2018-09-07 | 88 | 0 |
| K180019 | CAAS Workstation | Pie Medical Imaging BV | 2018-05-03 | 121 | 0 |
| K162991 | YELLOW 560 Fluorescence Module | Carl Zeiss Meditec, AG | 2017-07-24 | 270 | 0 |
| K170239 | Leica FL560 | Leica Microsystems (Schweiz) AG | 2017-07-05 | 160 | 0 |
| K151780 | CAAS Workstation | Pie Medical Imaging BV | 2016-03-11 | 254 | 0 |
| K141136 | LEICA FL800 | Leica Biosystems Richmond | 2014-08-19 | 110 | 0 |
| K133719 | PDE-NEO | Hamamatsu Photonics K.K. | 2014-03-27 | 112 | 0 |
| K133993 | CAAS WORKSTATION | Pie Medical Imaging | 2014-03-25 | 89 | 0 |
| K130003 | XIRALITE FLOURESCENCE IMAGING SYSTEM X4 | Mivenion GmbH | 2014-01-31 | 394 | 0 |
| K130842 | ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALL | Philips Medical Systems Nederland B.V. | 2013-05-21 | 55 | 65 |
| K113594 | C-THV SYSTEM | Paieon, Inc. | 2012-03-02 | 88 | 0 |
| K113034 | GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM | GE Healthcare | 2011-12-13 | 63 | 0 |
| K111209 | INTEGRATED INNOVA - S5I SYSTEM OPTION | GE Healthcare | 2011-07-26 | 88 | 1 |
| K110256 | THE IC-PRO SYSTEM | Paieon, Inc. | 2011-05-27 | 119 | 0 |
| K100371 | SPY INTRA-OPERATIVE IMAGING SYSTEM | Novadaq Technologies, Inc. | 2011-02-04 | 357 | 0 |
| K100849 | SYNC-RX SYSTEM, MODEL AS00010 | Sync-Rx, Ltd. | 2010-05-21 | 56 | 0 |
| K100468 | ZEISS INFRARED 800 WITH FLOW 800 OPTION | Carl Zeiss Surgical GmbH | 2010-03-03 | 13 | 0 |
| K090745 | ARTIS ZEE / ZEEGOS WITH SW VC14 | Siemens Medical Solutions USA, Inc. | 2009-06-18 | 90 | 6 |
| K083745 | THE IC-PRO SYSTEM, MODEL VERSION 3.2 | Paieon, Inc. | 2009-02-17 | 63 | 0 |
| K082907 | IC-PRO SYSTEM, VERSION 3.1.0.4 | Paieon, Inc. | 2008-11-18 | 49 | 0 |
| K073328 | CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA | Paieon, Inc. | 2008-09-09 | 287 | 0 |
| K080612 | LEICA FL800 | Leica Microsystems (Schweiz) AG | 2008-05-09 | 66 | 0 |
| K073290 | ARTIS ZEE AND ZEEGO | Siemens Medical Solutions USA, Inc. | 2008-02-11 | 82 | 19 |
| K073130 | SPY FLUORESCENT IMAGING SYSTEM | Novadaq Technologies, Inc. | 2008-01-10 | 65 | 0 |
| K073088 | SPY FLUORESCENT IMAGING SYSTEM | Novadaq Technologies, Inc. | 2008-01-10 | 70 | 0 |
| K071619 | SPY FLUORESCENT IMAGING SYSTEM | Novadaq Technologies, Inc. | 2007-11-09 | 149 | 2 |
| K072591 | CARDIOP-B SYSTEM, VERSION 2.1 | Paieon, Inc. | 2007-10-10 | 26 | 0 |
| K072222 | SPY FLUORESCENT IMAGING SYSTEM | Novadaq Technologies, Inc. | 2007-09-07 | 28 | 0 |
| K072006 | DAR-9400F | Shimadzu Corp. | 2007-08-31 | 39 | 0 |
| K071717 | GE OEC ALTITUDE | Shimadzu Corp. | 2007-07-05 | 13 | 0 |
| K071037 | SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000 | Novadaq Technologies, Inc. | 2007-05-10 | 28 | 0 |
| K063345 | SPY IMAGING SYSTEM | Novadaq Technologies, Inc. | 2007-01-12 | 67 | 0 |
| K062360 | BRANSIST SAFIRE | Shimadzu Corp. | 2006-10-05 | 52 | 1 |
| K061871 | LEICA MODEL FL800 | Leica Microsystems, Inc. | 2006-09-20 | 79 | 0 |
| K060867 | SPY INTRAOPERATIVE IMAGING SYSTEM | Novadaq Technologies, Inc. | 2006-05-03 | 34 | 0 |
| K060749 | XPERCT | Philips Medical Systems North America Co. | 2006-04-04 | 15 | 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