Cleared Traditional

Modus IR

K231986 · Synaptive Medical, Inc. · Neurology
Mar 2024
Decision
264d
Days
Class 2
Risk

About This 510(k) Submission

K231986 is an FDA 510(k) clearance for the Modus IR, a System, X-ray, Angiographic (Class II — Special Controls, product code IZI), submitted by Synaptive Medical, Inc. (Toronto, CA). The FDA issued a Cleared decision on March 25, 2024, 264 days after receiving the submission on July 5, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 892.1600.

Submission Details

510(k) Number K231986 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 2023
Decision Date March 25, 2024
Days to Decision 264 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code IZI — System, X-ray, Angiographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1600

Similar Devices — IZI System, X-ray, Angiographic

All 196
IC-Flow? Imaging System 2.0
K243645 · Diagnostic Green GmbH · Sep 2025
Affirm 800
K243077 · Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) · Jun 2025
EXPLORER AIR? II (8001, 8002, 8003); EXPLORER AIR? Sterile Drape (8004)
K234090 · Surgvision GmbH · Mar 2024
Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)
K231075 · Carl Zeiss Meditec, Inc. · Jun 2023
SPY Portable Handheld Imaging (SPY-PHI) System
K230727 · Novadaq Technologies Ulc (A Part of Stryker) · Jun 2023
EXPLORER AIR? II
K222240 · Surgvision GmbH · Feb 2023