FDA.reportPublic FDA data

Biim iOS App, P1.2

Primary DI
07090045490143
Brand
Biim iOS App, P1.2
Company
Biim Ultrasound AS
Model
P001157
Catalog number
P001157
Device description
Biim iOS App, P1.2
Published
2018-01-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
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
07090045490143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07090045490143070900454901437090045490143

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

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
07090045490136Adapter Bracket, Biim UltrasoundP001160P0011602018-01-26
07090045490150Biim Android App, P1.2P001158P0011582018-01-26
07090045490181Biim iOS App, P1.3P001227P0012272018-10-03

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Primary DI, Brand, Company table
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00841436125413Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125444CradleCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125451Classic StepperCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125819Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125833Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125857Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436126045Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436126281Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
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00841436126656Multi-Purpose Workstation ™ StepperCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436126663CradleCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
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