Synchrony— 510(k) K253473
Substantially EquivalentStereotaxis, Inc.
FDA 510(k) clearance K253473 for Synchrony, Substantially Equivalent on 2026-04-01. Applicant: Stereotaxis, Inc.. Device class: 2.
Clearance details
- Applicant
- Stereotaxis, Inc.
- Product code
- Code DQK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1425
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Saint Louis, MO, US
Recent devices under product code DQK
view allMore clearances from Stereotaxis, Inc.
view all- K262744 — GenesisX RMN
- K251792 — Stereotaxis GenesisX RMN with Navigant Workstation (NWS)
- K250590 — MAGiC Sweep EP Mapping Catheter
- K193147 — Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System
- K192775 — Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri
Adverse events under product code DQK
product code DQK- Death
- 10
- Injury
- 225
- Malfunction
- 2,123
- Other
- 2
- Total
- 2,360
Source: openFDA MAUDE database, through . 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.