FDA.reportPublic FDA data

Vue PACS

Primary DI
60889971047809
Brand
Vue PACS
Company
CARESTREAM HEALTH, INC.
Model
Vue PACS
Catalog number
1149418
Device description
UNLIMITED READING LIC < 25K EX/YR
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LLZSystem, image processing, radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110919000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110919000CARESTREAM PACSCarestream Health, Inc.2011-10-20LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60889971047809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6088997104780960889971047809

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS-dedicated management softwareA software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.

Regulatory Flags#

DUNS number
793169512
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
60889976701171CARESTREAM Image SuiteCARESTREAM Image Suite67011712022-02-25
60889971001894Vue Cardio PACSVue Cardio PACS10018902016-09-16
60889971029881DRX - Ascend SystemDRX - Ascend System10298832017-07-24
60889971041692Vue PACSVue PACS12012842016-09-16
60889971048875Vue MotionVue Motion10179792016-09-16
60889971055989CARESTREAM Image SuiteCARESTREAM Image Suite10559872016-09-16
60889978624188DRX-Compass X-ray SystemDRX-Compass X-ray System86241812022-01-11
60889971739193DRX-Evolution Plus SystemDRX-Evolution Plus System17391922016-09-16
60889978007257DRX-Revolution Mobile X-ray SystemDRX-Revolution Mobile X-ray System80072542016-09-16
60889976565667CARESTREAM DRX-EVOLUTIONCARESTREAM DRX-EVOLUTION65656672016-09-16
40889971067506CS 7200CS 720010675032016-09-16
40889971067513CS 7200CS 720010675112016-09-16
40889971337227CS 7400CS 740013372292016-09-16
40889978214231CS 7400CS 740082142312016-09-16
40889978427969CS 7400CS 740084279652016-09-16
40889978666948CS 7400CS 740086669432016-09-16
60889976579336Vita Flex CR SystemVita Flex CR System65793382019-08-03
60889976579343Vita Flex CR SystemVita Flex CR System65793462019-08-03
60889976579367Vita Flex CR SystemVita Flex CR System65793612019-08-03
60889971746337Vita Flex CR Long Length Imaging SystemVita Flex CR Long Length Imaging System17463382020-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
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00817886020677JointsMEDSTRAT, INC.LLZ2026-02-16
00817886020660JointsMEDSTRAT, INC.LLZ2025-08-09
00817886020653JointsMEDSTRAT, INC.LLZ2025-06-27
00817886020646JointsMEDSTRAT, INC.LLZ2025-04-30
00817886020639JointsMEDSTRAT, INC.LLZ2025-03-07
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00817886020622JointsMEDSTRAT, INC.LLZ2025-02-03
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00817886020615JointsMEDSTRAT, INC.LLZ2024-12-09
00817886020608JointsMEDSTRAT, INC.LLZ2024-11-01
00817886020592JointsMEDSTRAT, INC.LLZ2024-08-31
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00817886020585JointsMEDSTRAT, INC.LLZ2024-06-08
00817886020578JointsMEDSTRAT, INC.LLZ2024-04-12
00817886020561JointsMEDSTRAT, INC.LLZ2024-02-10
00817886020554JointsMEDSTRAT, INC.LLZ2023-11-13
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
00817886020516JointsMEDSTRAT, INC.LLZ2023-05-29
00817886020509JointsMEDSTRAT, INC.LLZ2023-04-03
00817886020493JointsMEDSTRAT, INC.LLZ2023-03-06
00195278517340ViewPointGE Healthcare GmbHLLZ2023-02-15
00817886020486JointsMEDSTRAT, INC.LLZ2023-01-20
00670082000511Modus PlanSynaptive Medical IncLLZ2022-12-13
00817886020479JointsMEDSTRAT, INC.LLZ2022-10-29
00817886020462JointsMEDSTRAT, INC.LLZ2022-09-05
00817886020455JointsMEDSTRAT, INC.LLZ2022-08-01
00817886020448JointsMEDSTRAT, INC.LLZ2022-06-17