FDA.reportPublic FDA data

F37

Primary DI
04573596214145
Brand
F37
Company
FUJIFILM CORPORATION
Model
F37
Device description
Diagnostic Ultrasound System
Published
2021-07-14
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
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122341000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122341000PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37Hitachi Aloka Medical, Ltd.2012-09-26IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04562122957878PreviousGS10
04573596214145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04562122957878045621229578784562122957878
04573596214145045735962141454573596214145

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose ultrasound imaging systemA stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Handling Environment Temperature50 Degrees Celsius104 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature14 Degrees Celsius122 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
680160734
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04573596212318S3ESCLSS3ESCLS2024-01-25
04573596212325S3ESELS3ESEL2021-07-18
04573596201367OASISMR-NVC-120OASIS RAPID NV Coil MR-NVC-1202026-05-29
04573596201398OASISMR-QFC-120OASIS QD Flexible Body Coil(L) MR-QFC-1202026-05-29
04573596201404OASISMR-QFC-120XLOASIS QD Flexible Body Coil(XL) MR-QFC-120XL2026-05-29
04573596201411OASISMR-RFC-120OASIS RAPID Foot Coil MR-RFC-1202026-05-29
04573596201435OASISMR-CTL-120OASIS CTL Coil MR-CTL-1202026-05-29
04573596202159OASISMR-IBC-120OASIS RAPID Breast Coil MR-IBC-1202026-05-29
04547410480269FUJIFILMVS-10002026-05-22
04547410529128FUJIFILMEG-S100XT2026-05-22
04573596200865APERTO LucentMR-JCR-82Joint coil (M) MR-JCR-82 for APERTO Lucent/APEROT 2026-05-22
04573596200889APERTO LucentMR-JC-81Joint coil (S) MRJC-81 for APERTO Lucent/APERTO Et2026-05-22
04573596200896APERTO LucentMR-JCR-83Joint coil (L) MR-JCR-83 for APERTO Lucent/APEROT 2026-05-22
04573596200902APERTO LucentMR-CSC-81C-Spine coil MR-SCS-81 for APERTO Lucent/APERTO Et2026-05-22
04573596200940APERTO LucentMR-QWC-81Wrist coil MR-QWC-81 for APERTO Lucent/Aperto Eter2026-05-22
04573596200964APERTO LucentMR-MSC-81Shoulder coil MR-MSC-81 for APERTO Lucent/APERTO E2026-05-22
04573596200971APERTO LucentMR-QRC-81Head coil (L) MR-QRC-81 for APERTO Lucent/APERTO E2026-05-22
04573596201480APERTO LucentMR-QHC-81RQD Head coil R MR-QHC-81R for APERTO Lucent2026-05-22
04573596201497APERTO LucentMR-QKC-83RQD Knee coil R MR-QKC-83R for APERTO Lucent2026-05-22
04573596201503APERTO LucentMR-IBC-83Open body coil MR-IBC-83 for APERTO Lucent/APERTO 2026-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841517112011iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517112011iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112011iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112028iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112028iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517112028iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCIYN2026-07-10
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCITX2026-07-10
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCIYO2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCITX2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCIYN2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCIYO2026-07-10
06938396440008SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2026-07-10
06938396440008SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYN2026-07-10
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.IYN2026-06-24
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.IYO2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.IYN2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.IYO2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.IYO2026-06-24