Identity
- Trade Name
- Monarch Software Laptop v2.1.6 FDA UDI
- Generic Name
- CT system application software FDA UDI
- Device Name
- Monarch Software Laptop v2.1.6 FDA UDI
- Model / Reference
- Version 2.1.6 FDA UDI
- Description
- Monarch Software Laptop v2.1.6 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B634SW0121900201060 FDA UDI
- 510(k) Number
- K173760 FDA UDI
- FDA Product Code
- EOQ FDA UDIJAK FDA UDI
- GMDN Term
- CT system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4680 FDA UDI892.1750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: CT system application software
Monarch Software Laptop v2.1.6 by Auris Health, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as CT system application software.
- QCT Bone Mineral Density Analysis Software — Mindways Software, Inc. · Class II
- AI-Rad Companion (Cardiovascular) — Siemens Healthcare · Class II
- VeraLook CTC CAD — Icad, Inc. · Class II
- syngo.CT Dual Energy — Siemens Healthcare · Class II
- Monarch™ Software Laptop v2.1.2 — Auris Health, Inc. · Class II
- LungPrint — VIDA DIAGNOSTICS · Class II
- QCT PRO 3D Volumetric Spine and CTXA Hip Software — Mindways Software, Inc. · Class II
- syngo.CT Extended Functionality — Siemens Healthcare · Class II
Cleared under the same submission
K173760 also covers:
- Biopsy Forceps - Smooth Cup — Auris Health, Inc
- Bronchoscope Fluidics Tubing — Auris Health, Inc
- Bronchoscope Patient Introducer Kit — Auris Health, Inc
- Bronchoscope Sheath Valve — Auris Health, Inc
- Bronchoscope Sheath Valve — Auris Health, Inc
- Bronchoscope Valve — Auris Health, Inc
- Cytology Brush — Auris Health, Inc
- Monarch Endoscopy Platform (P1) Tower Upgrade — Auris Health, Inc
- Monarch Software Laptop v2.2.1 — Auris Health, Inc
- Monarch Software Tower v2.1.6 — Auris Health, Inc
- Monarch™ Bronchoscope System — Auris Health, Inc
- Monarch™ Platform — Auris Health, Inc
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Auris Health, Inc
Sources (1)
- FDA UDI ebe87c3c-7f8e-4536-a392-645cea0c2ecd 34 fields · synced Jun 4, 2026