Chrysalis Intelligence · Sponsors · Synaptive Medical, Inc.

Synaptive Medical, Inc.

Toronto, CA · 3 510(k) clearances · 3 recalls

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Total clearances
3
2020-04-29 → 2024-03-25
Last 12 months
0
Product codes
2
Most recent
2024-03-25
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
LNH — — — 2 2023-10-11
IZI — — — 1 2024-03-25
Safety

Recalls (3)

Class I (serious)
0
Risk of injury / death
Total recalls
3
Currently ongoing
0
Most recent
2021-04-23
DateSeverityStatusRecall # ProductCodeReason
2021-04-23 Class II Terminated Z-1955-2021 Synaptive Trackable Suction Set Standard and Malleable — Due to visible burrs/metal filings affixed along the suction tube inner perimeter.
2020-02-26 Class II Terminated Z-1759-2020 Synaptive ImageDrive Clinical — A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
2020-02-26 Class II Terminated Z-1758-2020 ClearCanvas RIS/PACS — A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
Filings

All 510(k) clearances (3)

Date K-number Device Code Class Specialty
2024-03-25 K231986 Modus IR IZI — —
2023-10-11 K232981 Synq Software Version 1.3 LNH — —
2020-04-29 K200327 Evry LNH — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence