Product code IZI
- Device name
- System, X-Ray, Angiographic
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.1600
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261037 | 780 nm SPY Portable Handheld Imaging (SPY-PHI) System | Stryker Endoscopy | 2026-05-28 |
| K253181 | SURGIMAGE SIM 1000H Fluorescence Imaging Platform | Surgimage Corporation | 2026-05-13 |
| K243645 | IC-Flow™ Imaging System 2.0 | Diagnostic Green GmbH | 2025-09-22 |
| K243077 | Affirm 800 | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | 2025-06-27 |
| K231986 | Modus IR | Synaptive Medical, Inc. | 2024-03-25 |
| K234090 | EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) | Surgvision GmbH | 2024-03-20 |
| K231075 | Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) | Carl Zeiss Meditec, Inc. | 2023-06-20 |
| K230727 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc (A Part of Stryker) | 2023-06-05 |
| K222240 | EXPLORER AIR® II | Surgvision GmbH | 2023-02-28 |
| K214097 | Explorer Air II | Surgvision GmbH | 2022-02-25 |
| K202391 | DIR 800 | Aesculap, Inc. | 2021-01-21 |
| K192761 | Asimov-MKS Imaging System | Onlume, Inc. | 2020-01-17 |
| K190772 | SURGICAL MICROSCOPE SYSTEM ORBEYE with IR | Olympus Medical Systems Corp. | 2019-10-10 |
| K182907 | SPY Elite Intraoperative Perfusion Assessment System | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2019-01-23 |
| K181537 | GLOW800 | Leica Microsystems (Schweiz) AG | 2018-09-07 |
| K180019 | CAAS Workstation | Pie Medical Imaging BV | 2018-05-03 |
| K162991 | YELLOW 560 Fluorescence Module | Carl Zeiss Meditec, AG | 2017-07-24 |
| K170239 | Leica FL560 | Leica Microsystems (Schweiz) AG | 2017-07-05 |
| K151780 | CAAS Workstation | Pie Medical Imaging BV | 2016-03-11 |
| K141136 | LEICA FL800 | Leica Biosystems Richmond | 2014-08-19 |
| K133719 | PDE-NEO | Hamamatsu Photonics K.K. | 2014-03-27 |
| K133993 | CAAS WORKSTATION | Pie Medical Imaging | 2014-03-25 |
| K130003 | XIRALITE FLOURESCENCE IMAGING SYSTEM X4 | Mivenion GmbH | 2014-01-31 |
| K130842 | ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES | Philips Medical Systems Nederland B.V. | 2013-05-21 |
| K113594 | C-THV SYSTEM | Paieon, Inc. | 2012-03-02 |
| K113034 | GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM | GE Healthcare | 2011-12-13 |
| K111209 | INTEGRATED INNOVA - S5I SYSTEM OPTION | GE Healthcare | 2011-07-26 |
| K110256 | THE IC-PRO SYSTEM | Paieon, Inc. | 2011-05-27 |
| K100371 | SPY INTRA-OPERATIVE IMAGING SYSTEM | Novadaq Technologies, Inc. | 2011-02-04 |
| K100849 | SYNC-RX SYSTEM, MODEL AS00010 | Sync-Rx, Ltd. | 2010-05-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08600105136202 | RE3 | Digital Surgery Systems, Inc. | 2025-07-15 |
| 10193489068184 | NAMIC | MEDLINE INDUSTRIES, INC. | 2023-12-21 |
| 10193489068191 | NAMIC | MEDLINE INDUSTRIES, INC. | 2023-12-21 |
| 10193489068207 | NAMIC | MEDLINE INDUSTRIES, INC. | 2023-12-21 |
| 10193489068092 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2023-09-15 |
| 10193489140170 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2023-09-15 |
| 10841962118733 | Iris AirShuttle™ | Qfix | 2023-04-10 |
| 10193489059038 | NAMIC | MEDLINE INDUSTRIES, INC. | 2021-07-26 |
| 10193489058833 | NAMIC | MEDLINE INDUSTRIES, INC. | 2021-07-26 |
| 10193489058826 | NAMIC | MEDLINE INDUSTRIES, INC. | 2021-07-26 |
| 10193489059458 | NAMIC | MEDLINE INDUSTRIES, INC. | 2021-07-26 |
| 10858701006213 | SPY | Novadaq Technologies Inc | 2020-09-21 |
| 07613327502800 | Pinpoint | STRYKER CORPORATION | 2019-07-30 |
| 08054890480109 | Discovery RF180 | GENERAL MEDICAL MERATE SPA | 2018-07-11 |
| 08054890480055 | CLISIS SYSTEMS | GENERAL MEDICAL MERATE SPA | 2018-07-11 |
| 08056304453433 | CAAS MR 4D Flow | Pie Medical Imaging B.V. | 2017-06-02 |
| 08056304453051 | CAAS MR 4D Flow | Pie Medical Imaging B.V. | 2017-01-18 |
| 08056304451149 | CAAS A-Valve | Pie Medical Imaging B.V. | 2016-09-27 |
| 10858701006176 | PINPOINT PAQ | Novadaq Technologies Inc | 2016-09-23 |
| 10858701006268 | SPY PAQ | Novadaq Technologies Inc | 2016-09-23 |
| H965904008390 | NAMIC | NAVILYST MEDICAL, INC. | 2016-09-20 |
| H965904000390 | NAMIC | NAVILYST MEDICAL, INC. | 2016-09-20 |
| H965640460070 | NAMIC | NAVILYST MEDICAL, INC. | 2016-09-20 |
| H965640009550 | NAMIC | NAVILYST MEDICAL, INC. | 2016-09-20 |
| H965640000900 | NAMIC | NAVILYST MEDICAL, INC. | 2016-09-20 |
| H965640000100 | NAMIC | NAVILYST MEDICAL, INC. | 2016-09-20 |
| H749904004350 | NAMIC | NAVILYST MEDICAL, INC. | 2016-09-20 |
| 04987670100222 | INTERVENTIONAL ANGIOGRAPHY SYSTEM | CANON INC. | 2016-09-01 |
| H965804008390 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H749850004350 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |