Modus IR— 510(k) K231986

Name: FDA 510(k) clearance K231986
Creator: U.S. Food and Drug Administration
Published: 2024-03-25

Substantially Equivalent

Synaptive Medical, Inc.

FDA 510(k) clearance K231986 for Modus IR, Substantially Equivalent on 2024-03-25. Applicant: Synaptive Medical, Inc.. Device class: 2.

Clearance details

Applicant: Synaptive Medical, Inc.
Product code: Code IZI
Device class: Class 2
Regulation: 21 CFR 892.1600
Advisory panel: Radiology
Date received: 2023-07-05
Decision date: 2024-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code IZI

view all

K261037 — 780 nm SPY Portable Handheld Imaging (SPY-PHI) System2026-05-28
K253181 — SURGIMAGE SIM 1000H Fluorescence Imaging Platform2026-05-13
K243645 — IC-Flow Imaging System 2.02025-09-22
K243077 — Affirm 8002025-06-27
K234090 — EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)2024-03-20

More clearances from Synaptive Medical, Inc.

view all

K232981 — Synq Software Version 1.32023-10-11
K200327 — Evry2020-04-29
K183325 — Modus Nav2019-07-14
K180394 — BrightMatter Plan 1.6.02018-03-09
K160523 — BrightMatter Guide with BrightMatter Pointer2016-06-24

Adverse events under product code IZI

product code IZI

Death: 9
Malfunction: 5,312
Total: 5,321

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.