FDA.reportPublic FDA data

NaviCam ESView 3.X

Primary DI
00810164590794
Brand
NaviCam ESView 3.X
Company
ANX ROBOTICA CORP
Model
ESView 3.X
Catalog number
SB-US-2026
Device description
The NaviCam ESView 3.X software is used with the NaviCam SB System to analyze images to create a video for the physician to review after a capsule endoscopy procedure.
Published
2026-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Product Codes#

Code, Name table
CodeName
NEZSystem, Imaging, Gastrointestinal, Wireless, Capsule

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEZSystem, Imaging, Gastrointestinal, Wireless, CapsuleGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233229000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233229000NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam TetherAnx Robotica Corporation2024-01-05NEZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810164590794PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810164590794008101645907948101645907940810164590794

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
024972857
Device count
1
Lot or batch
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
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
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
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
00810164590114NaviCam Data RecorderANX ROBOTICA CORPNEZ2026-02-16
00810164590145NaviCam LocatorANX ROBOTICA CORPNEZ2026-02-16
00810164590169NaviCam ESView SoftwareANX ROBOTICA CORPNEZ2026-02-16
00810164590008NaviCam SB CapsuleANX ROBOTICA CORPNEZ2026-02-09
00810164590039NaviCam SB Capsule/TetherANX ROBOTICA CORPNEZ2026-02-09
00810164590718NaviCam XS CapsuleANX ROBOTICA CORPNEZ2026-02-09
00810164590732NaviCam XS Capsule/TetherANX ROBOTICA CORPNEZ2026-02-09
00867770000278CE Deliver CAPSOVISION, INC.NEZ2026-01-08
00867770000285CE Deliver CAPSOVISION, INC.NEZ2026-01-08
10884521845848PillCam GeniusGiven Imaging, Inc.NEZ2024-11-29
20884521845845PillCam GeniusGiven Imaging, Inc.NEZ2024-11-29
10884521846975PillCam GeniusGiven Imaging, Inc.NEZ2024-11-29
10884521845831PillCam GeniusGiven Imaging, Inc.NEZ2024-11-14
10884521845916PillCamGiven Imaging, Inc.NEZ2024-11-14
10884521845923PillCamGiven Imaging, Inc.NEZ2024-11-14
10884521836181PillCamGiven Imaging, Inc.NEZ2023-10-05
04953170214288RECORDER UNIT HARNESSOLYMPUS MEDICAL SYSTEMS CORP.NEZ2023-06-21
04953170231001CAPSULE ENDOSCOPE SYSTEM A-SETOLYMPUS MEDICAL SYSTEMS CORP.NEZ2023-06-21
04953170231032ANTENNA LEAD SETOLYMPUS MEDICAL SYSTEMS CORP.NEZ2023-06-21
04953170244506RECORDER UNITOLYMPUS MEDICAL SYSTEMS CORP.NEZ2023-06-21
04953170245657RECORDER UNIT CRADLEOLYMPUS MEDICAL SYSTEMS CORP.NEZ2023-06-21
04953170360817ENDOCAPSULE SOFTWARE 10 SOFT SERVER-CLIENTOLYMPUS MEDICAL SYSTEMS CORP.NEZ2023-06-21
04953170360824ENDOCAPSULE SOFTWARE 10 SOFTWARE CLIENTOLYMPUS MEDICAL SYSTEMS CORP.NEZ2023-06-21
06921010800494 NaviCam Small Bowel Capsule Endoscopy SystemANKON Technologies Co.,Ltd.NEZ2022-12-27
06921010800500 NaviCam Small Bowel Capsule Endoscopy SystemANKON Technologies Co.,Ltd.NEZ2022-12-27
16921010800491 NaviCam Small Bowel Capsule Endoscopy SystemANKON Technologies Co.,Ltd.NEZ2022-12-27
16921010800507 NaviCam Small Bowel Capsule Endoscopy SystemANKON Technologies Co.,Ltd.NEZ2022-12-27
06921010800517 NaviCam Small Bowel Capsule Endoscopy SystemANKON Technologies Co.,Ltd.NEZ2022-12-27
06921010800524 NaviCam Small Bowel Capsule Endoscopy SystemANKON Technologies Co.,Ltd.NEZ2022-12-27
06921010800531 NaviCam Small Bowel Capsule Endoscopy SystemANKON Technologies Co.,Ltd.NEZ2022-12-27