SURGIMAGE SIM 1000H Fluorescence Imaging Platform
FDA 510(k) K253181 · Surgimage Corporation
510(k) numberK253181
Submission
- Device name
- SURGIMAGE SIM 1000H Fluorescence Imaging Platform
- Applicant
- Surgimage Corporation
Taipei City, TW - Received
- September 26, 2025
- Decision date
- May 13, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IZI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261037 | 780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemIZI · Traditional | Stryker Endoscopy | 05/28/2026SE |
| K243645 | IC-Flow Imaging System 2.0IZI · Traditional | Diagnostic Green GmbH | 09/22/2025SE |
| K243077 | Affirm 800IZI · Traditional | Digital Surgery Systems, Inc. (D.B.A True… | 06/27/2025SE |
| K231986 | Modus IRIZI · Traditional | Synaptive Medical, Inc. | 03/25/2024SE |
| K234090 | EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)IZI · Traditional | Surgvision GmbH | 03/20/2024SE |
| K231075 | Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)IZI · Traditional | Carl Zeiss Meditec, Inc. | 06/20/2023SE |
| K230727 | SPY Portable Handheld Imaging (SPY-PHI) SystemIZI · Traditional | Novadaq Technologies Ulc (A Part of Stryker) | 06/05/2023SE |
| K222240 | Explorer Air® IIIZI · Traditional | Surgvision GmbH | 02/28/2023SE |
| K214097 | Explorer Air IIIZI · Traditional | Surgvision GmbH | 02/25/2022SE |
| K202391 | Dir 800IZI · Traditional | Aesculap, Inc. | 01/21/2021SE |
Questions and answers
When was SURGIMAGE SIM 1000H Fluorescence Imaging Platform cleared by the FDA?
SURGIMAGE SIM 1000H Fluorescence Imaging Platform (K253181) received a 510(k) decision of Substantially Equivalent on May 13, 2026, 229 days after the submission was received.
What is the product code of K253181?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.