FDA.reportPublic FDA data

Centricity

Primary DI
00840682104821
Brand
Centricity
Company
GE HEALTHCARE
Model
CPACS RA1000 6.0
Published
2019-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110875000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110875000CENTRICITY PACSGE Healthcare2011-05-05LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682104821PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682104821008406821048218406821048210840682104821

GMDN Terms#

Term, Definition table
TermDefinition
Radiology PACS softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images. It is designed specifically for use within radiology.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
054324257
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198953043387MR Contour DL159863452026-01-23
00840682152754GraffitiNotifyMe V1.02021-09-27
00840682102681CENTRICITYPERINATAL6.962016-07-01
00840682123785CentricityPerinatal6.972017-04-17
00195278263919Digital Expert Access12021-04-07
00195278644039Universal Viewer8.12024-10-02
00195278707741Digital Expert Accesswith Remote scanning for MR59416112024-06-21
00840682124447CentricityCPACS RA1000 4.02022-04-29
00840682145558CentricityCPACS 7.02020-02-06
00840682104807CentricityCPACS 6.02016-08-01
00840682124430CentricityCPACS 4.02017-11-07
00840682125260CA10002.0 SP 142017-10-18
00840682145572CentricityCPACS 7.02020-01-27
00195278379610Universal Viewer82021-07-15
00840682102988CENTRICITYUNIVERSAL VIEWER ZFP CLIENT 6.02016-08-01
00840682103800CENTRICITYUNIVERSAL VIEWER 6.02016-08-01
00840682145794CENTRICITYUNIVERSAL VIEWER 7.02020-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506092176ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-17
00888867561793Arthrex®ARTHREX, INC.GCJ2026-07-17
B382SD90781001000Surgical DirectSurgical Direct, Inc.GCJ2026-07-17
B382SD9918100Surgical DirectSurgical Direct, Inc.GCJ2026-07-17
B382SD1184590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD12711090Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271390Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13018770Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13168350Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD23373490Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD770561050Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD775011530Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD775021630Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD77505650Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD7751586C0Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD7751587C0Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
00850045863012ArthroFree® 2 ReceiverLazurite Holdings LLCGCJ2026-07-10
00850045863029ArthroFree® 2 Wireless Camera HeadLazurite Holdings LLCGCJ2026-07-10
00850045863036ArthroFree® 2 Operating Room KitLazurite Holdings LLCGCJ2026-07-10
00850045863043ArthroFree® 2 Single Camera Head SetLazurite Holdings LLCGCJ2026-07-10
B382SD883110450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
B382SD88324450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
00190776421731MillenniumAvalign Technologies, Inc.GCJ2026-06-24
00190776421663MillenniumAvalign Technologies, Inc.GCJ2026-06-23
00190776421687MillenniumAvalign Technologies, Inc.GCJ2026-06-23
00198506091506ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-10
00198506044366ELMEDELMED INCORPORATEDGCJ2026-06-09
00812231033906PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033913PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08