Archimedes System

Basic Information

• Brand Name: Archimedes System
• Primary DI: 00856571007036
• Version / Model: 40005
• Catalog Number: 40005
• Company Name: BRONCUS MEDICAL INC.
• Labeler DUNS: 078684808
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-27
• Public Version: 6
• Public Version Date: 2019-05-23
• Public Version Status: Update
• Public Device Record Key: 467aa96c-d80f-424a-8336-f55bb0c3609f

Device Description

Archimedes software is installed on a desktop computer used to plan procedures and navigate to targets in the lung. The Procedure Module offers real-time navigation guidance for use during the bronchoscopy procedure. The Software provides the option to segment previously acquired CT or other DICOM data sets and overlay and register these segmented data sets onto live fluoroscopic X-ray images. The software allows visualization of the bronchial tree; helps guide the tools in or adjacent to the bronchial tree; allows visualization of a predefined target in lung tissue; and assists with placement of markers into soft lung tissue to guide radiosurgery and thoracic surgery.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LLZ	System, Image Processing, Radiological	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58042	Virtual bronchoscopic navigation PACS software	A software application intended to add specific image processing and/or analysis capabilities to a picture archiving and communication system (PACS) used for virtual bronchoscopic navigation (VBN). It is typically used by a bronchoscopist as a navigation system to help plan and provide guidance of a flexible bronchoscope to predefined target sites [also referred to as region of interest (ROI)] in the lung tissue of the tracheobronchial tree. It typically uses computed tomography (CT) scans in digital imaging and communications in medicine (DICOM) format. This software is typically installed in an off-the-shelf desktop or laptop computer.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856571007036	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K133385	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Room Temperature