FDA.reportPublic FDA data

CHILI PACS

Primary DI
04260456230062
Brand
CHILI PACS
Company
CHILI GmbH
Model
4.64.0
Device description
CHILI PACS 4.64.0
Published
2019-03-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe

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
K070796000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070796000CHILI PACSChili GmbH2007-04-06LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260456230062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260456230062042604562300624260456230062

GMDN Terms#

Term, Definition table
TermDefinition
Radiology picture archiving and communication system workstationA freestanding, image processing device that is a component of a picture archiving and communication system (PACS) for radiology designed to be networked with a wide variety of diagnostic imaging systems [e.g., x-ray, nuclear medicine, magnetic resonance imaging (MRI) or ultrasound (US), as well as a laboratory or hospital information system (HIS)]. It does not contain controls for the direct operation of a diagnostic imaging system and is designed to receive, archive, and transmit data both on-line and off-line. It is configured to provide limited or extensive capabilities to further process, manipulate and/or view patient images and information collected from diagnostic imaging systems.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
331736095
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260456230208CHILI PACS4.92.02026-04-20
04260456230192CHILI PACS4.90.02026-01-08
04260456230185CHILI PACS4.88.02025-07-31
04260456230178CHILI PACS4.86.02025-01-13
04260456230161CHILI PACS4.84.02024-05-21
04260456230154CHILI PACS4.82.02023-02-01
04260456230147CHILI PACS4.80.02022-08-09
04260456230130CHILI PACS4.78.02022-02-10
04260456230123CHILI PACS4.76.02021-08-03
04260456230116CHILI PACS4.74.02021-03-31
04260456230109CHILI PACS4.72.02020-08-11
04260456230093CHILI PACS4.70.02020-03-20
04260456230079CHILI PACS4.66.02019-05-27
04260456230000CHILI PACS4.522017-02-14
04260456230017CHILI PACS4.542017-09-01
04260456230024CHILI PACS4.562017-09-01
04260456230031CHILI PACS4.582018-01-11
04260456230048CHILI GmbH4.602018-05-18
04260456230055CHILI PACS4.62.02018-10-11
04260456230086CHILI PACS4.68.02019-11-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00866463000496STAGESpintech, Inc.LLZ2026-07-23
00854810007229iCRco Clarity ViewerIcRco, Inc.LLZ2026-07-22
17540262200102Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-07-22
17540262090161Change Healthcare CardiologyChange Healthcare Canada CompanyLLZ2026-07-21
M722CP26183V261830ClearRead CT Platform DockerRiverain Technologies, Inc.LLZ2026-07-17
00854393006084VelocityVARIAN MEDICAL SYSTEMS, INC.LLZ2026-07-16
G874AVARAVIEWER0010Avara ViewerAVARA SOFTWARE LLCLLZ2026-07-13
06938396401528SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401559SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
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
06938396401658SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
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
G775EVOLVE4140EVOLVESmaart Medical Systems, Inc.LLZ2026-07-09
080563044562053mensio WorkstationPie Medical Imaging B.V.LLZ2026-07-08
00850059977576TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977583TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977590TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977606TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977613TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977521TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977538TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977545TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977552TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977569TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26