HITACHI

Primary DI
04562122957014
Brand
HITACHI
Company
HITACHI, LTD.
Model
UST-9120
Device description
Probe Compatible with waterproof cover
Published
2016-09-13
Public version status
Update
Distribution status
Not 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
K032875000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032875000ALOKA MODEL SSD-5500 V6.0 ULTRASOUND SYSTEMAloka Co. Ltd USA2003-09-30IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04562122957014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04562122957014045621229570144562122957014

GMDN Terms#

Term, Definition table
TermDefinition
Surgical ultrasound imaging transducerA hand-held ultrasound imaging transducer assembly designed to be positioned within a surgical site for localized intraoperative imaging applications. It is sometimes referred to as a surgical probe or fingertip probe. It steers, focuses, and detects the ultrasound beam and resulting echoes either mechanically or electronically. This group of devices includes ultrasound imaging transducer assemblies used with A-mode, B-mode, M-mode, Doppler, colour Doppler (CD), and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities. This is a reusable device.

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
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method
"[""Liquid Chemical"", ""Peracetic Acid"", ""Hydrogen Peroxide"", ""Ethylene Oxide""]"
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide

Regulatory Flags#

DUNS number
693002605
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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04562122951562HITACHIMP-24502018-09-23
04562122951616HITACHIMP-2748-SET2018-09-24
04562122951630HITACHIMP-2445-G142018-09-24
04562122951647HITACHIMP-2445-G162018-09-24
04562122951654HITACHIMP-2445-G172018-09-24
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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

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