FDA.reportPublic FDA data

PillCam

Primary DI
07290110360795
Brand
PillCam
Company
Given Imaging, Inc.
Model
FGS-0665
Device description
PillCam™ Remote Reading Software
Published
2021-10-16
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170210000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170210000PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0Given Imaging , Ltd.2017-09-01NEZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290110360795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290110360795072901103607957290110360795

GMDN Terms#

Term, Definition table
TermDefinition
Video capsule endoscopy system application softwareA software program intended to be used with a video capsule endoscopy system control unit or an off-the-shelf computer to receive, display, process and/or manage (e.g., communicate, store) photographic image data from an ingested video capsule (not included), and/or to adjust capsule settings [e.g., position in the gastrointestinal (GI) tract]. It is intended for use by a healthcare professional in a clinical setting.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
090073722
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290101365921ManoScanFGS-05712017-07-20
07290101369578ManoViewFGS-06282019-08-11
10884521855441ManoScanFGS-07152025-08-21
07290101364221PillCamRFB-03472017-02-02
04260167480954ManoScan38852016-09-24
04260167480961ManoScan38872016-09-24
04260167482446ManoScan38902016-09-24
04260167482460ManoScan21952016-09-24
04260167482477ManoScan21922016-09-24
04260167482484ManoScan12862016-09-24
07290101365686PillCamRFB-01542016-09-24
10884521853317ManoScanFGS-80382025-01-25
10884521846975PillCam GeniusFGS-08062024-11-29
10884521845848PillCam GeniusFGS-06892024-11-29
20884521845845PillCam GeniusFGS-06892024-11-29
10884521845831PillCam GeniusFGS-06882024-11-14
10884521845916PillCamFGS-08022024-11-14
10884521845923PillCamFGS-08032024-11-14
10884521836181PillCamFGS-07072023-10-05
07290101364474PillcamRFB-03552017-02-02

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