FDA.reportPublic FDA data

MiroCam Capsule Endoscope System

Primary DI
08809260260429
Brand
MiroCam Capsule Endoscope System
Company
IntroMedic Co., LTD.
Model
MR1000-S
Published
2017-12-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
K140751000
K143663000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140751000MIROCAM CAPSULE ENDOSCOPE SYSTEMIntromedic Co., Ltd.2014-06-30NEZ
K143663000MiroCam Capsule Endoscope SystemIntromedic Co., Ltd.2015-03-17NEZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809260260429PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809260260429088092602604298809260260429

GMDN Terms#

Term, Definition table
TermDefinition
Video capsule endoscopy systemAn assembly of electronic devices designed for the internal visualization and examination of sections of the gastrointestinal (GI) tract using a non-digestible video capsule after it has been swallowed by a patient. The system typically consists of an operator workstation, various types of video capsules, an external sensor device that receives the wireless signals from the capsule, and a data recorder. As the capsule passes through the GI tract, video images of it sections (e.g., oesophagus, small bowel and colon) are relayed to the operator for examination and data recording; the capsule is egested from the gut.

Regulatory Flags#

DUNS number
631065794
Device count
1
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809260260566MiroCam Capsule Endoscope SystemMC1200-B2020-09-09
08809260260573MiroCam Capsule Endoscope SystemMC2000-B2020-09-09
08809260260580MiroCam Capsule Endoscope SystemMC1600-B2020-09-09
18809260260563MiroCam Capsule Endoscope SystemMC1200-B2020-09-09
18809260260570MiroCam Capsule Endoscope SystemMC2000-B2020-09-09
18809260260587MiroCam Capsule Endoscope SystemMC1600-B2020-09-09
08809260260351MiroCam Capusle Endoscope SystemMC2000-B2018-02-12
08809260260443MiroCam Capsule Endoscope SystemMC1200-B, MR20002018-03-12
08809260260191MiroCam Capsule Endoscope SystemMR20002018-02-12
08809260260269MiroCam Capsule Endoscope SystemMC1000-B2017-01-31
08809260260290MiroCam Capsule Endoscope SystemMC1200-B2017-01-31
08809260260436MiroCam Capusle Endoscope System MC2000-B, MR20002018-02-12
08809260260320MiroCam Capsule Endoscope SystemMC1600-B2019-06-17
08809260260498MiroCam Capsule Endoscope SystemMC1600-B, MR20002019-06-17
18809260260358MiroCam Capusle Endoscope SystemMC2000-B2018-02-12
98809260260446MiroCam Capsule Endoscope SystemMC1200-B, MR20002018-03-12
08809260260184MiroCam Capsule Endoscope SystemMR11002017-01-31
08809260260375MiroCam Capsule Endoscope SystemMC1000-B, MR11002017-01-31
08809260260382MiroCam Capsule Endoscope SystemMC1200-B, MR11002017-01-31
08809260260405MiroCam Capsule Endoscope SystemMR1000-D(M)2017-12-05

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
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