FDA.reportPublic FDA data

PACS Scan

Primary DI
00850677007006
Brand
PACS Scan
Company
HYLAND LLC
Model
5
Device description
PACS Scan Software
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K083618000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083618000PACS SCANPacsgear, Inc.2009-01-28LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850677007006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850677007006008506770070068506770070060850677007006

GMDN Terms#

Term, Definition table
TermDefinition
Radiography digital imaging scannerA laser or light-based optical unit designed to convert medical images originally captured on x-ray film or phosphor storage plate (PSP) into a digital format. Examples of this device include devices employing video frame grabbers, and scanners which use lasers or charge-coupled devices. Depending on the design, the digitized images can then be digitally transferred from location to location, archived, or used with other digital image processing, analysis or recording systems.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079941872
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850677007129Media Writer52019-03-12
00850677007136Media Writer CD52019-03-12
00850677007327GearView QC3X2020-09-30
00850677007396PACSgear Enterprise Server5.1.X2020-11-13
00850677007389Image Link Plus1.X2021-02-26
00850677007419PACSgear Enterprise Server5.2.XCS.5.22021-02-26
00850677007341GearView Basic3X2020-09-30
00850677007259PACSgear Enterprise Server5.X2020-04-10
00850677007266EHR-Gateway 3.X2020-04-10
00850677007273ModLink Web Forms4.X2020-04-10
00850677007280PACS Scan Web3.X2020-04-10
00850677007297Image Link3.X2020-04-10
00850677007303Image Link Encounter Workflow2.X2020-04-10
00850677007310EHR-Gateway Print 2.X2020-04-10
00850677007150PACS Scan Mobile2.2.XPSM2.2.22019-12-27
00850677007167PACSgear Core Server4.X2019-12-27
00850677007181PACSgear PACS Scan Web2.X2019-12-27
00850677007198PACSgear Image Link2.X2019-12-27
00850677007204PACSgear Image Link Encounter Workflow1.X2019-12-27
00850677007211PACSgear Mod Link3.X2019-12-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401597SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401603SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401634SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
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06938396401702SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401719SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396410124SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
04260483290305MeVis AVM ContourMeVis Medical Solutions AGLLZ2026-07-09
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00850059977521TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977538TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
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00850059977552TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977569TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
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00889024699786ROSA® ShoulderOrthosoft IncLLZ2026-06-26
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