Skip to content

Modus IR

by Synaptive Medical Inc

510(k) K231986

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK231986 Date25 Mar 2024ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
IZI
FDA applicant
Synaptive Medical, Inc.
Device class
Class II
Regulation
21 CFR Part 892.1600
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Modus IR is a Near-Infrared Fluorescence Imaging Module designed as an accessory for surgical exoscopes. It enables intraoperative visualization of vascular structures and blood flow using fluorescence imaging, enhancing surgical precision under white light limitations. The device leverages optical signal detection to highlight anatomical features not visible conventionally, supporting procedures in radiology and neurosurgery.

Supplied as a reusable accessory for integration with Synaptive’s surgical exoscope systems, the Modus IR operates in controlled clinical environments such as operating rooms. It is classified as a Class II medical device under FDA regulations (21 CFR 892.1600) and holds a 510(k) clearance (K231986) for substantial equivalence. No sterility or single-use specifications are noted; compatibility is limited to compatible exoscope platforms. MRI safety and storage conditions are not detailed in the regulatory submission.

Devices cleared under K231986

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K231986
UDI-DISize and differences
Modus IR SYN-0990
Synaptive Medical Inc
SYN-099000670082000603 —On the market

Similar devices

Other devices filed under FDA product code IZI (System, X-Ray, Angiographic).

Other devices from Synaptive Medical Inc

See all devices from Synaptive Medical Inc →