FDA.reportPublic FDA data

Butterfly iQ+ Bladder Ultrasound System

Primary DI
00850027593081
Brand
Butterfly iQ+ Bladder Ultrasound System
Company
Butterfly Network, Inc.
Model
850-20028
Published
2024-05-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200980000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200980000Auto 3D Bladder Volume ToolButterfly Network, Inc.2020-06-11IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850027593081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850027593081008500275930818500275930810850027593081

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held ultrasound imaging system, body-surfaceA battery-powered, hand-held device/device assembly designed to be placed over the external body surface for collection, display, and analysis of ultrasound information during a variety of ultrasound imaging procedures (i.e., non-dedicated); it may in addition be intended to be used with a sterile cover for intraoperative imaging. It consists of a flat- or concave-lensed ultrasound transducer and includes an integrated image processing system; it may include an integrated display or be intended to wirelessly transmit images to an off-the-shelf device (e.g., smartphone, tablet) with dedicated software installed. It is not designed to be inserted into the vagina or rectum.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117520495
Device count
1
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00866646000206Butterfly Network, Inc.Butterfly iQ2018-08-10
00850027593135Butterfly iQ3 Ultrasound System850-200332025-12-10
00850027593111BUTTERFLY MOBILE DEVICE CHARGING KIT815-20072-002024-09-11
00850027593128Butterfly iQ3 Charger Kit815-20054-012024-09-04
00850027593036BUTTERFLY IQ3 ACCESSORY CABLE, LIGHTNING C78, USB2.0, 1.50M490-00227-022024-02-14
00850027593043BUTTERFLY IQ3 ACCESSORY CABLE, LIGHTNING C78, USB2.0, 2.50M490-00227-032024-02-14
00850027593050BUTTERFLY IQ3 ACCESSORY CABLE, USB-C, USB2.0, 1.50M490-00228-022024-02-14
00850027593067BUTTERFLY IQ3 ACCESSORY CABLE, USB-C, USB2.0, 2.50M490-00228-032024-02-14
00850027593074Butterfly iQ3 Charger Kit815-20054-002024-02-14
00850027593029Butterfly iQ3 Ultrasound System850-200262024-02-13
00850027593005LIGHTNING CABLE ASSEMBLY, USB 2.0, 2.50 meter490-00189-032021-03-10
00850027593012USB-C CABLE ASSEMBLY, USB 2.0, 2.50 meter490-00187-032021-03-10
00866646000275LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.50 meter490-00183-02, 490-00189-022020-12-21
00866646000305LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.50 meter490-00183-02, 490-00189-022020-09-29
00866646000213BUTTERFLY iQ+850-200142020-09-29
00866646000220USB-C CABLE ASSEMBLY, USB 2.0, 1.25 meter490-00187-002020-09-29
00866646000237USB-C CABLE ASSEMBLY, USB 2.0, 2.00 meter490-00187-012020-09-29
00866646000244LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.25 meter490-00183-00, 490-00189-002020-09-29
00866646000251LIGHTNING CABLE ASSEMBLY, USB 2.0, 2.00 meter490-00183-01, 490-00189-012020-09-29
00866646000268BUTTERFLY iQ/iQ+ WIRELESS CHARGER KITWTD1A052020-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850050934233EndoSound® EVS ProbeEndosound, Inc.ITX2026-06-01
00850050934240EndoSound® EVS SideBeam 5103Endosound, Inc.IYO2026-06-01
00850050934257EndoSound® Coax Transducer Extension Connector (TEC)Endosound, Inc.IYO2026-06-01
00850050934264EndoSound® EVS SideBeam 5105 (4 pouches)Endosound, Inc.IYO2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.ITX2026-05-29
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.IYO2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
08056304455826MyLabC25ESAOTE SPAIYO2025-12-10
08056304455826MyLabC25ESAOTE SPAITX2025-12-10
08056304455833MyLabC30ESAOTE SPAIYO2025-12-10
08056304455833MyLabC30ESAOTE SPAITX2025-12-10
08056304455017MyLabA50ESAOTE SPAITX2025-07-07
08056304455017MyLabA50ESAOTE SPAIYO2025-07-07
08056304455215MyLabE85ESAOTE SPAITX2025-07-07
08056304455215MyLabE85ESAOTE SPAIYO2025-07-07
08056304455307MyLabA70ESAOTE SPAIYO2025-07-07
08056304455307MyLabA70ESAOTE SPAITX2025-07-07
08056304455437MyLabA50ESAOTE SPAITX2025-07-07
08056304455437MyLabA50ESAOTE SPAIYO2025-07-07
08056304455451MyLabA70ESAOTE SPAITX2025-07-07
08056304455451MyLabA70ESAOTE SPAIYO2025-07-07
08056304455635MyLabE80ESAOTE SPAITX2025-07-07
08056304455635MyLabE80ESAOTE SPAIYO2025-07-07
08056304455642MyLabE85ESAOTE SPAITX2025-07-07
08056304455642MyLabE85ESAOTE SPAIYO2025-07-07