FDA.reportPublic FDA data

HITACHI

Primary DI
04562122958639
Brand
HITACHI
Company
HITACHI, LTD.
Model
DAS-RS1
Device description
ULTRASOUND DATA ANALYSIS SYSTEM
Published
2019-07-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
K081843000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081843000ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1Aloka Co., Ltd.2008-07-15LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04562122958639PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04562122958639045621229586394562122958639

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
693002605
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
04560333350280PROBEATSmall Field Applicator for PROBEAT-V2026-01-20
04560333350204PROBEATPROBEAT-FR2024-01-19
04560333350211PROBEATMini Ridge Filter and auxiliary functions for PROB2023-12-20
04560333350228PROBEATReal Time Image Gating System for Proton Beam Ther2023-12-20
04560333350198PROBEATSmall Field Applicator for PROBEAT-V2023-10-02
04560333350006PROBEATPROBEAT-CR2019-09-24
04562122951555HITACHIMP-2445-SET2018-09-24
04562122951562HITACHIMP-24502018-09-23
04562122951616HITACHIMP-2748-SET2018-09-24
04562122951630HITACHIMP-2445-G142018-09-24
04562122951647HITACHIMP-2445-G162018-09-24
04562122951654HITACHIMP-2445-G172018-09-24
04562122951661HITACHIMP-2445-G182018-09-24
04562122951678HITACHIMP-2445-G222018-09-24
04562122951685HITACHIMP-2452-G162018-09-24
04562122951692HITACHIMP-2452-G182018-09-24
04562122951708HITACHIMP-2748-G162018-09-24
04562122951715HITACHIMP-2748-G172018-09-24
04562122951722HITACHIMP-2748-G182018-09-24
04562122956260HITACHIMP-24482018-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953050996SnapShot FreezeGE Medical Systems, L.L.C.LLZ2026-10-19
05745000308385Cercare Medical NeurosuiteCercare Medical A/SLLZ2026-10-17
05745000308392Cercare Medical Neurosuite with Capillary FunctionCercare Medical A/SLLZ2026-10-17
05745000308408Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertCercare Medical A/SLLZ2026-10-17
05745000308361Cercare Oncology Virtual Expert; CMN Capillary Function with Oncology Virtual ExCercare Medical A/SLLZ2026-10-16
75401622502301Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-10-16
00889024713390ROSA® ShoulderOrthosoft IncLLZ2026-10-15
B037FFSMD0Synapse MobilityResolutionMD Inc.LLZ2026-10-15
B037NLIVD0Nicolab Image ViewerResolutionMD Inc.LLZ2026-10-15
B037RESMDD0ResolutionMDResolutionMD Inc.LLZ2026-10-15
00860013868918MICSI-PETMicroStructure Imaging, Inc.LLZ2026-10-14
00745426000059MiPACS V5Medicor ImagingLLZ2026-10-12
75401622522132Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-10-08
00198953200421EchoPACGE Vingmed Ultrasound A/SLLZ2026-10-07
00198953200438EchoPACGE Vingmed Ultrasound A/SLLZ2026-10-07
17540262200126Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-10-05
00884838120433SmartCTPhilips Medical Systems Nederland B.V.LLZ2026-09-28
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00889024673403NavitrackER®Orthosoft IncLLZ2026-06-26
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
05745000308323Cercare Medical Neurosuite with Capillary FunctionCercare Medical A/SLLZ2026-01-30
05745000308330Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertCercare Medical A/SLLZ2026-01-30
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00195278951700EchoPACGE Vingmed Ultrasound A/SLLZ2025-08-08
00195278951717EchoPACGE Vingmed Ultrasound A/SLLZ2025-08-08