FDA.reportPublic FDA data

Adapter Bracket, Biim Ultrasound

Primary DI
07090045490136
Brand
Adapter Bracket, Biim Ultrasound
Company
Biim Ultrasound AS
Model
P001160
Catalog number
P001160
Device description
Adapter Bracket, Biim Ultrasound
Published
2018-01-26
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
K173138000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173138000Biim Diagnostic Ultrasound SystemBiim Ultrasound AS2017-10-27IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07090045490136PackageGS11In Commercial Distribution
07090045490129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07090045490136070900454901367090045490136
07090045490129070900454901297090045490129

GMDN Terms#

Term, Definition table
TermDefinition
Extracorporeal ultrasound imaging transducer, hand-heldA hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
671316618
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
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
07090045490365Biim Ultrasound L12-4 Linear Array Transducer (Version P2.0)P001000-04P001000-042019-10-21
07090045490327Biim iOS App, P2.0P001424P0014242019-09-24
07090045490334Biim Android App, P2.0P001425P0014252019-09-24
07090045490358Battery Charger AU, Biim UltrasoundP001253P0012532019-09-24
07090045490273Battery Charger UK, Biim UltrasoundP001197P0011972019-01-10
07090045490266Battery Charger EU, Biim UltrasoundP001198P0011982019-01-10
07090045490242Battery Charger UK, Biim UltrasoundP001197P0011972019-01-10
07090045490303Biim iOS App, P1.3.2P001417P0014172019-01-09
07090045490310Biim Android App, P1.3.2P001418P0014182019-01-09
07090045490006Biim Ultrasound L12-4 Linear Array TransducerP001000P0010002018-01-26
07090045490051Probe holder, (V2) Biim UltrasoundP001137P0011372018-01-26
07090045490129Adapter Bracket, Biim UltrasoundP001160P0011602018-01-26
07090045490013Biim iOS App, P1.1P001117P0011172018-01-26
07090045490020Biim Android App, P1.1P001118P0011182018-01-26
07090045490037Battery, Biim UltrasoundP001050P0010502018-01-26
07090045490068Probe Holder, (V1) Biim UltrasoundP001175P0011752018-01-26
07090045490099Battery Charger, Biim UltrasoundP001052P0010522018-01-26
07090045490143Biim iOS App, P1.2P001157P0011572018-01-26
07090045490150Biim Android App, P1.2P001158P0011582018-01-26
07090045490181Biim iOS App, P1.3P001227P0012272018-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M722CD26127V260970ClearRead CT DockerRiverain Technologies, Inc.LLZ2026-05-28
17540262200096Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-05-27
75401622522101Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-05-27
08437021722093ADAS 3DADAS3D MEDICAL S.L.LLZ2026-05-12
08800133400003ZeTTA PACSTae Young Soft Co., Ltd.LLZ2026-05-12
08033837938835no brandCEFLA SOCIETA' COOPERATIVALLZ2026-05-11
G725QFR300QFRQFR Solutions B.V.LLZ2026-05-11
G725QFR310QFRQFR Solutions B.V.LLZ2026-05-11
08800130800080Laon OrthoLaon Medi Inc.LLZ2026-05-07
G713ELU0010ElucisRealize Medical Inc.LLZ2026-05-07
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.LLZ2026-05-06
08437023642016NemoCastSOFTWARE NEMOTEC SLLLZ2026-04-23
08437023642023NemoFABSOFTWARE NEMOTEC SLLLZ2026-04-23
M722C26103V260970ClearRead CT ServerRiverain Technologies, Inc.LLZ2026-04-20
M722CC26103V260970ClearRead CT ConsoleRiverain Technologies, Inc.LLZ2026-04-20
M722CD26103V260970ClearRead CT DockerRiverain Technologies, Inc.LLZ2026-04-20
M722CP26104V261040ClearRead CT Platform DockerRiverain Technologies, Inc.LLZ2026-04-20
EOLENEUROINSIGHTV1P00Neuro InsightOlea Medical USALLZ2026-04-13
EOLENEUROVASIV1P00Neurovascular InsightOlea Medical USALLZ2026-04-13
08056304455864Caas QardiaPie Medical Imaging B.V.LLZ2026-04-03
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800066200619JLK-AILINKJLK, Inc.LLZ2026-03-25
08800066200787JLK-CTPJLK, Inc.LLZ2026-03-25
08800066200794JLK-PWIJLK, Inc.LLZ2026-03-25
08800130400303Neurophet AQUA AD PlusNEUROPHET Inc.LLZ2026-02-24
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.LLZ2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.LLZ2026-01-28
08800290041811EA2-11ARSAMSUNG MEDISON CO., LTD.LLZ2026-01-28