FDA.reportPublic FDA data

Archimedes System

Primary DI
00856571007036
Brand
Archimedes System
Company
BRONCUS MEDICAL INC.
Model
40005
Catalog number
40005
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.
Published
2017-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133385000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133385000LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWAREBroncus Medical, Inc.2014-02-26LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856571007036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856571007036008565710070368565710070360856571007036

GMDN Terms#

Term, Definition table
TermDefinition
Virtual bronchoscopic navigation PACS softwareA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room Temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
650-428-1600CustomerSupport@Broncus.com

Regulatory Flags#

DUNS number
078684808
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856571007265EasyPath RF Introducer Sheath100112026-04-23
00856571007913BroncTru™ Transbronchial Access ToolAK-82-702025-03-31
00856571007920BroncTru™ Transbronchial Access ToolAK-64-602025-03-31
00856571007937BroncTru™ Transbronchial Access ToolAK-46-552025-03-31
00856571007944BroncTru™ Transbronchial Access ToolAK-91-552025-03-31
00856571007951BroncTru™ Transbronchial Access ToolAK-82-002025-03-31
00856571007968BroncTru™ Transbronchial Access ToolAK-64-002025-03-31
00856571007975BroncTru™ Transbronchial Access ToolAK-46-002025-03-31
00856571007982BroncTru™ Transbronchial Access ToolAK-91-002025-03-31
08565710078012BioStar Transbronchial Aspiration NeedleiS2372024-08-19
08565710078029BioStar Transbronchial Aspiration NeedleiS2272024-08-19
00856571007296Archimedes Access Kit10009-910009-92021-10-04
00856571007241Empower RF Catheter10010100102019-11-01
00856571007104Archimedes Planning System40009400092017-06-27
00856571007128LungPoint Planning System, v3.230009300092017-06-27
00856571007173LungPoint VBN System, V3.230005300052017-06-27
00856571007227Archimedes Access Key10009-110009-12017-12-12
00856571007258Archimedes Access Key, 10-pack10009-210009-22019-02-21
00856571007012FleXNeedle10005-110005-12017-05-12
00856571007029Archimedes Access Kit10009100092017-06-27

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