FDA.reportPublic FDA data

NaviCam Capsule Endoscope System

Primary DI
00850015518195
Brand
NaviCam Capsule Endoscope System
Company
ANX ROBOTICA CORP
Model
Stomach Capsule/AKEM-11SW
Catalog number
CP-US-7006
Device description
The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stomach System” in short), is a novel 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 to be controlled by an operator.
Published
2020-12-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

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
DEN190037000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN190037000NaviCam Capsule Endoscope System with NaviCam Stomach CapsuleAnx Robotica, Inc.2020-05-22QKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850015518195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850015518195008500155181958500155181950850015518195

GMDN Terms#

Term, Definition table
TermDefinition
Video capsule endoscopy system capsuleAn electrically-powered, non-digestible capsule containing a video camera designed to pass through the gastrointestinal (GI) tract of a patient after being swallowed or endoscopically introduced, for the internal visualization and examination of the GI tract. It is intended to acquire video images of GI tract sections (e.g., oesophagus, small bowel and colon) and wirelessly transmit the images to a dedicated control unit/monitor (not included) via an external sensor array for examination and data recording. The capsule can be freely mobile or externally controlled by another device (not included); the capsule is excreted from the gut. This is a single-use device.

Regulatory Flags#

DUNS number
024972857
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850015518003IntraMarX Radiopaque MarkersAGIROMC1-1(R)AGIROMC1-1(R)2020-01-27
00850015518010IntraMarX Radiopaque MarkersAGIROMC1-1(DD)AGIROMC1-1(DD)2020-01-27
00850015518027IntraMarX Radiopaque MarkersAGIROMC1-1(TC)AGIROMC1-1(TC)2020-01-27
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
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
00810164590817MotiliCap GI Monitoring System Mobile Phone/AppMO-US-8010MO-US-80102026-02-09
00850015518287NaviCam TetherCEE-1ES-US-30022023-01-05
00850015518294NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach SystemController/ NaviEC-2000MC-US-10022023-01-05
00850015518072NaviCam Stomach SystemLocator AKS-1SB-US-20062020-12-08
00850015518188NaviCam Capsule Endoscope SystemRecorder/AKR-1MC-US-10062020-12-08
00850015518201NaviCam Capsule Endoscope SystemController/NaviEC-1000MC-US-10012020-12-08
00850015518232IntraMarX 3DCombo2020-12-08
00850015518126IntraMarXAGIROMC1-1-R/1AGIROMC1-1-R/12020-07-08
00850015518133IntraMarXAGIROMC1-1-DD/1AGIROMC1-1-DD/12020-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850015518287NaviCam TetherANX ROBOTICA CORPQKZ2023-01-05
00850015518294NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach SystemANX ROBOTICA CORPQKZ2023-01-05
00850015518072NaviCam Stomach SystemANX ROBOTICA CORPQKZ2020-12-08
00850015518188NaviCam Capsule Endoscope SystemANX ROBOTICA CORPQKZ2020-12-08
00850015518201NaviCam Capsule Endoscope SystemANX ROBOTICA CORPQKZ2020-12-08