Product code IZI
- Product
- System, X-ray, Angiographic
- Description
- Radiology Medical Diagnostic X-Ray Equipment
- Regulation number
- 892.1600
- Radiation type
- Ionizing
- Applicable standards
- Diagnostic X-ray Systems And Their Major Components. [1020.30] Radiographic Equipment. [1020.31] Fluoroscopic Equipment. [1020.32] Computed Tomography (CT) Equipment. [1020.33]
Current FDA Classification
- 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
Related Records
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K100468 | ZEISS INFRARED 800 WITH FLOW 800 OPTION | Carl Zeiss Surgical GmbH | 2010-03-03 |
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| 00841962119474 | Alpine Stirrups | Qfix | 2025-07-09 |
| 04049539070166 | YELLOW 560 | Carl Zeiss Meditec AG | 2024-10-07 |
| 08800060100243 | ENDURO DR | REMEDI CO.,LTD. | 2024-09-20 |
| 08800060100236 | ENDORO DR ES70 X-ray Source | REMEDI CO.,LTD. | 2024-07-23 |
| 07630802402615 | GLOW800 | Leica Microsystems (Schweiz) AG | 2024-05-03 |
| 04260721460002 | EXPLORER AIR II | SurgVision GmbH | 2024-04-26 |
| 00670082000603 | Modus IR | Synaptive Medical Inc | 2024-04-02 |
| 20193489068181 | NAMIC | MEDLINE INDUSTRIES, INC. | 2023-12-21 |
| 20193489068198 | NAMIC | MEDLINE INDUSTRIES, INC. | 2023-12-21 |
| 20193489068204 | NAMIC | MEDLINE INDUSTRIES, INC. | 2023-12-21 |
| 20193489140177 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2023-09-15 |
| 20193489068099 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2023-09-15 |
| 04582389010871 | PDE-GEN3 | HAMAMATSU PHOTONICS K.K. | 2023-06-01 |
| 00195278524904 | Optima | Hangwei GE Medical Systems Co., Ltd. | 2022-10-20 |
| 00195278524911 | Optima | Hangwei GE Medical Systems Co., Ltd. | 2022-10-20 |
| 04056869295923 | ARTIS icono ceiling | Siemens Healthcare GmbH | 2022-10-01 |
| 04953170396113 | INFRARED AND BLUE LIGHT FILTER UNIT | OLYMPUS MEDICAL SYSTEMS CORP. | 2022-07-25 |
| 08800060100151 | REMEX KA6 | REMEDI CO.,LTD. | 2022-04-13 |
| 00886874122228 | Endowrist SP | INTUITIVE SURGICAL, INC. | 2022-01-28 |
| 10860001790297 | Sterimed | STERIMED LLC | 2021-09-29 |
| 10860007655606 | Sterimed | STERIMED LLC | 2021-09-29 |
| 20193489058823 | NAMIC | MEDLINE INDUSTRIES, INC. | 2021-07-26 |
| 20193489058830 | NAMIC | MEDLINE INDUSTRIES, INC. | 2021-07-26 |
| 20193489058991 | NAMIC | MEDLINE INDUSTRIES, INC. | 2021-07-26 |
| 20193489059028 | NAMIC | MEDLINE INDUSTRIES, INC. | 2021-07-26 |
| 10193489066920 | NAMIC | MEDLINE INDUSTRIES, INC. | 2021-05-12 |
| 00858701006193 | SPY-PHI System | Novadaq Technologies Inc | 2017-03-31 |
| 20858701006265 | SPY PAQ® | Novadaq Technologies Inc | 2016-09-23 |