FDA.reportPublic FDA data

NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach System

Primary DI
00850015518294
Brand
NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach System
Company
ANX ROBOTICA CORP
Model
Controller/ NaviEC-2000
Catalog number
MC-US-1002
Device description
Controller. The NaviCam Xpress Stomach System is a endoscopic capsule imaging system intended to obtain images of the stomach. It differs from passive capsule endoscopy systems in that it uses magnetic fields to allow the position of the capsule within the stomach to be controlled by an operator
Published
2023-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QKZMagnetically Maneuvered Capsule Endoscopy System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKZMagnetically Maneuvered Capsule Endoscopy SystemGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203192000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203192000NaviCam Xpress Stomach SystemAnx Robotica Corp2021-05-04QKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850015518294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850015518294008500155182948500155182940850015518294

GMDN Terms#

Term, Definition table
TermDefinition
Video capsule endoscopy system capsule magnetic manipulation unitAn electrically-powered, noninvasive device designed to control/manoeuvre a video capsule endoscopy system capsule (not included) in the gastrointestinal (GI) tract. It typically consists of a large magnetic device intended to magnetically couple with the capsule (e.g., a robotic arm with a magnet at its distal end, whole-body magnetic bore), patient table, and computer/console with dedicated software and controls; it is not a one-piece, hand-held device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
770-480-2911tim.thomas@anxrobotics.com

Regulatory Flags#

DUNS number
024972857
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810164590114NaviCam Data RecorderSB-US-2003SB-US-20032026-02-16
00810164590145NaviCam LocatorSB-US-2006SB-US-20062026-02-16
00810164590169NaviCam ESView SoftwareESView 2.XSB-US-20062026-02-16
00810164590275NaviCam ProScan AI SoftwareSB-US-2025SB-US-2-252026-02-16
00810164590794NaviCam ESView 3.XESView 3.XSB-US-20262026-02-16
00810164590008NaviCam SB CapsuleCP-US-7001CP-US-70012026-02-09
00810164590039NaviCam SB Capsule/TetherES-US-3001ES-US-30012026-02-09
00810164590633MotiliCap GI Monitoring System Data RecorderMO-US-8001MO-US-80012026-02-09
00810164590640MotiliCap GI Monitoring System Software (MotiliScan)MO-US-8005MO-US-80052026-02-09
00810164590657MotiliCap GI Monitoring System CapsuleCP-US-7010CP-US-70102026-02-09
00810164590718NaviCam XS CapsuleCP-US-7009CP-US-70092026-02-09
00810164590732NaviCam XS Capsule/TetherES-US-3009ES-US-30092026-02-09
00810164590817MotiliCap GI Monitoring System Mobile Phone/AppMO-US-8010MO-US-80102026-02-09
00850015518287NaviCam TetherCEE-1ES-US-30022023-01-05
00850015518072NaviCam Stomach SystemLocator AKS-1SB-US-20062020-12-08
00850015518188NaviCam Capsule Endoscope SystemRecorder/AKR-1MC-US-10062020-12-08
00850015518195NaviCam Capsule Endoscope SystemStomach Capsule/AKEM-11SWCP-US-70062020-12-08
00850015518201NaviCam Capsule Endoscope SystemController/NaviEC-1000MC-US-10012020-12-08
00850015518003IntraMarX Radiopaque MarkersAGIROMC1-1(R)AGIROMC1-1(R)2020-01-27
00850015518010IntraMarX Radiopaque MarkersAGIROMC1-1(DD)AGIROMC1-1(DD)2020-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850015518287NaviCam TetherANX ROBOTICA CORPQKZ2023-01-05
00850015518072NaviCam Stomach SystemANX ROBOTICA CORPQKZ2020-12-08
00850015518188NaviCam Capsule Endoscope SystemANX ROBOTICA CORPQKZ2020-12-08
00850015518195NaviCam Capsule Endoscope SystemANX ROBOTICA CORPQKZ2020-12-08
00850015518201NaviCam Capsule Endoscope SystemANX ROBOTICA CORPQKZ2020-12-08