FDA.reportPublic FDA data

Power Park

Primary DI
00841517108328
Brand
Power Park
Company
FUJIFILM SONOSITE, INC.
Model
P30825-01
Catalog number
P30825
Device description
Accessory for Janus and Turbo
Published
2023-01-09
Public version status
New
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
OIJBiopsy Needle Guide Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
OIJBiopsy Needle Guide KitRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130173000
K162045000
K183235000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130173000SONOSITE MAXX SERIES ULTRASOUND SYSTEMFUJIFILM Sonosite, Inc.2013-03-25IYN
K162045000SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.2016-08-18IYN
K183235000SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.2019-02-07IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841517108328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841517108328008415171083288415171083280841517108328

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 Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-35 Degrees Celsius65 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-35 Degrees Celsius65 Degrees Celsius

Regulatory Flags#

DUNS number
014438860
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841517112622Sonosite STP31200-60P312002026-05-01
00841517112585L19-5P23972-25AP239722026-04-17
00841517112493C5-1P23119-30P231192026-03-30
00841517112561Sonosite PXP25000-60P250002026-03-12
00841517112530H-Universal StandP23119-25AP231192026-01-09
00841517112486rP19x/5-1 MHzP22557-11AP225572025-12-23
00841517112455L19-5P23972-25P239722025-12-18
00841517112479C5-1P23119-25P231192025-12-17
00841517111892Sonosite MTP33004-04P330042025-11-24
00841517112134Sonosite MTP33002-10P330022025-11-24
00841517112141Sonosite MTP33006-10P330062025-11-24
00841517112158Sonosite MTP33001-10P330012025-11-24
00841517112165Sonosite MTP33000-10P330002025-11-24
00841517112172Sonosite MTP33009-10P330092025-11-24
00841517112196Sonosite MTP33003-10P330032025-11-24
00841517112424Sonosite PXP25000-61P250002025-11-24
00841517112431Sonosite LXP28354-61P283542025-11-24
00841517112448Sonosite STP31200-61P312002025-11-24
00841517112288BatteryP31275-03P312752025-10-27
00841517112295BatteryP31058-03P310582025-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033737713037THD Procto Software SystemTHD SPAITX2021-07-19
08052461860046Echolight S.p.a.ECHOLIGHT SPAIYO2021-03-05
08056304454263MyLabSigma eliteESAOTE SPAIYO2020-10-23
08056304453891E 3-12ESAOTE SPAITX2019-12-20
08056304454096C 2-9ESAOTE SPAITX2019-12-20
08056304453419MyLabX8ESAOTE SPAIYN2019-12-20
08056304453419MyLabX8ESAOTE SPAIYO2019-12-20
08056304454126MyLabX8 eXPESAOTE SPAIYO2019-12-20
08056304454126MyLabX8 eXPESAOTE SPAIYN2019-12-20
08056304453518MyLabX6ESAOTE SPAIYN2019-06-13
08056304453518MyLabX6ESAOTE SPAITX2019-06-13
08056304453525MyLabX7ESAOTE SPAITX2019-06-13
08056304453525MyLabX7ESAOTE SPAIYO2019-06-13
08056304453563MyLabX5ESAOTE SPAITX2019-06-13
08056304453563MyLabX5ESAOTE SPAIYO2019-06-13
08056304453617MyLabOmegaESAOTE SPAIYO2019-06-13
08056304453617MyLabOmegaESAOTE SPAIYN2019-06-13
08056304453679MyLabSigmaESAOTE SPAIYN2019-06-13
08056304453679MyLabSigmaESAOTE SPAIYO2019-06-13
08056304453921MyLab 9ESAOTE SPAITX2019-06-13
08056304453921MyLab 9ESAOTE SPAIYN2019-06-13
08056304452658MyLab 9 eXPESAOTE SPAITX2018-02-19
08056304452658MyLab 9 eXPESAOTE SPAIYN2018-02-19
08056304452603MyLabEight eXPESAOTE SPAIYO2017-04-03
08056304452603MyLabEight eXPESAOTE SPAIYN2017-04-03
08056304452610MyLabEightESAOTE SPAITX2017-04-03
08056304452610MyLabEightESAOTE SPAIYO2017-04-03
08056304452597MyLabSeven ESAOTE SPAITX2017-02-24
08056304452597MyLabSeven ESAOTE SPAIYO2017-02-24
08056304453013MyLabOneEsaote Europe B.V.IYO2017-02-24