FDA.reportPublic FDA data

NaviCam Small Bowel Capsule Endoscopy System

Primary DI
06921010800517
Brand
NaviCam Small Bowel Capsule Endoscopy System
Company
ANKON Technologies Co.,Ltd.
Model
Recorder/AKR-1
Catalog number
MC-US-1006
Device description
The AKR-1 Data Recorder is a portable data receiving unit with built-in rechargeable lithium battery placed inside the examination cloth worn by the patient during examination. It is used for receiving image data wirelessly transmitted from the Capsule.
Published
2022-12-27
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
NEZSystem, Imaging, Gastrointestinal, Wireless, Capsule

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06921010800517PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06921010800517069210108005176921010800517

GMDN Terms#

Term, Definition table
TermDefinition
Video capsule endoscopy monitoring kitA collection of noninvasive devices intended to assist with the monitoring of image data from an ingested video capsule (not included), as it passes through the gastrointestinal (GI) tract. It typically consists of a monitor, an antenna that receives the wireless signals from the capsule, and additional devices utilized for the recording procedure (e.g., connection cables, holders, protectors); it may in addition include a capsule activator(s). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+8613397176599sifeng.wang@ankoninc.com.cn

Regulatory Flags#

DUNS number
549329633
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06921010800494 NaviCam Small Bowel Capsule Endoscopy SystemCapsule/AKES-11SW CP-US-7005, CP-US-70062022-12-27
06921010800500 NaviCam Small Bowel Capsule Endoscopy SystemCapsule/AKES-11SICP-US-7001, CP-US-70022022-12-27
16921010800491 NaviCam Small Bowel Capsule Endoscopy SystemCapsule/AKES-11SW CP-US-7005, CP-US-70062022-12-27
16921010800507 NaviCam Small Bowel Capsule Endoscopy SystemCapsule/AKES-11SICP-US-7001, CP-US-70022022-12-27
06921010800524 NaviCam Small Bowel Capsule Endoscopy SystemRecorder/AKRI-1SB-US-20032022-12-27
06921010800531 NaviCam Small Bowel Capsule Endoscopy SystemLocator/AKS-1SB-US-20062022-12-27

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
00810164590794NaviCam ESView 3.XANX 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
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