System, Imaging, Pulsed Echo, Ultrasonic

Product Code: IYO

Radiology Diagnostic Ultrasound Devices

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 892.1560


Radiation TypeAcoustic
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as IYO

5329System, Imaging, Pulsed Echo, UltrasonicUltrasonic Pulsed Echo Imaging System.

Total Product Life Cycle (TPLC) Devices

5329System, Imaging, Pulsed Echo, UltrasonicUltrasonic Pulsed Echo Imaging System.

FDA Consensus Standards

System, Imaging, Pulsed Echo, Ultrasonic [33222]21 CFR §892.1560 ๐Ÿ”Ž
System, Imaging, Pulsed Echo, Ultrasonic [37049]21 CFR §892.1560 ๐Ÿ”Ž
System, Imaging, Pulsed Echo, Ultrasonic [29909]21 CFR §892.1560 ๐Ÿ”Ž
System, Imaging, Pulsed Echo, Ultrasonic [37172]21 CFR §892.1560 ๐Ÿ”Ž
System, Imaging, Pulsed Echo, Ultrasonic [32093]21 CFR §892.1560 ๐Ÿ”Ž
System, Imaging, Pulsed Echo, Ultrasonic [32394]21 CFR §892.1560 ๐Ÿ”Ž
System, Imaging, Pulsed Echo, Ultrasonic [37039]21 CFR §892.1560 ๐Ÿ”Ž
System, Imaging, Pulsed Echo, Ultrasonic [33119]21 CFR §892.1560 ๐Ÿ”Ž
System, Imaging, Pulsed Echo, Ultrasonic [32393]21 CFR §892.1560 ๐Ÿ”Ž

Pre-market Notifications for IYO

K213411ISRโ€™obot Mona Lisa 2.0Biobot Surgical Pte Ltd
K213070MD-320W Ultrasound BiomicroscopeMeda Co., LTD
K212035FibroScan 230Echosens
K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.
K211623THD Procto Software SystemTHD SpA
K211193BD Prevue II Peripheral Vascular Vascular Access SystemBard Access Systems, Inc, (C.R. Bard, Inc.)
K211098Breast Volume Navigator (BVN) Model G-2000MetriTrack, Inc.
K210591Palm Bladder Scanner - PBSV7.1Mianyang Meike Electronic Equipment Co., Ltd.
K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)FCU Co., Ltd.
K203719IntraSight MobileVolcano Corporation
K203659ISR'obot Mona Lisa 1.0Biobot Surgical Pte Ltd
K203273FibroScanยฎ Family Of Products (Models: 502 Touch, 530 Compact, 430 Mini+, And 630)Echosens
K202119AcuSee AS-P1000 SystemWeipeng (Suzhou) Medical Devices Co., Ltd.
K201995CUBEScan BioCon-1100Mcube Technology Co., Ltd.
K201597Liver Incytes, Model 1005Sonic Incytes

Global Unique Device Identification Database

00382830041751System, Imaging, Pulsed Echo, Ultrasonic
00382830038201System, Imaging, Pulsed Echo, Ultrasonic
00382830038195System, Imaging, Pulsed Echo, Ultrasonic
00380657501236System, imaging, pulsed echo, ultrasonic
10380656786105System, imaging, pulsed echo, ultrasonic
00628055481027System, Imaging, Pulsed Echo, Ultrasonic
00628055481010System, Imaging, Pulsed Echo, Ultrasonic
00627825005562System, imaging, pulsed echo, ultrasonic
00627825005555System, imaging, pulsed echo, ultrasonic
00627825005524System, imaging, pulsed echo, ultrasonic
00627825005517System, imaging, pulsed echo, ultrasonic
50748426054010System, imaging, pulsed echo, ultrasonic
30748426053767System, imaging, pulsed echo, ultrasonic
50748426053969System, imaging, pulsed echo, ultrasonic
00748426053957System, imaging, pulsed echo, ultrasonic

Maude Adverse Events

SITE~RITE 8 ULTRASOUND SYSTEM 20 MM PINPOINT GTBARD ACCESS SYSTEMS2020-03-27
SITE-RITE 8 ULTRASOUND SYSTSEM CONSOLE (REMANUFACTURED)BARD ACCESS SYSTEMS2020-03-26
SITE~RITE 8 CE ULTRASOUND SYSTEMBARD ACCESS SYSTEMS2020-03-25
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-25
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-25
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-25
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-25
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-25
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-25
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-25
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-25
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-25
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-25
SITE~RITE PREVUE + ULTRASOUND SYSTEMBARD ACCESS SYSTEMS2020-03-25
SITE-RITE 8 ULTRASOUND SYSTSEM CONSOLE (REMANUFACTURED)BARD ACCESS SYSTEMS2020-03-25
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-24
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-24
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-20
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-20
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-20
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-20
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-20
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-20
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-20
SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTORBARD ACCESS SYSTEMS2020-03-20
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-20
REFURB, SITE-RITE PREVUEBARD ACCESS SYSTEMS2020-03-20
SITE-RITE 8 ULTRASOUND SYSTSEM CONSOLE (REMANUFACTURED)BARD ACCESS SYSTEMS2020-03-19
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-19
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-12
SITE-RITE 8 ULTRASOUND SYSTSEM CONSOLE (REMANUFACTURED)BARD ACCESS SYSTEMS2020-03-12
REFURB, SITE-RITE 8BARD ACCESS SYSTEMS2020-03-12
SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTORBARD ACCESS SYSTEMS2020-03-11
SITE~RITE 8 ULTRASOUND SYSTEM 20 MM PINPOINT GTBARD ACCESS SYSTEMS2020-03-11
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-11
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-11
SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTORBARD ACCESS SYSTEMS2020-03-11
SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTORBARD ACCESS SYSTEMS2020-03-11
SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTORBARD ACCESS SYSTEMS2020-03-11
SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTORBARD ACCESS SYSTEMS2020-03-11
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-05
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-05
SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTORBARD ACCESS SYSTEMS2020-03-05
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-05
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-05
SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTORBARD ACCESS SYSTEMS2020-03-05
SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTORBARD ACCESS SYSTEMS2020-03-05
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-05
SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTORBARD ACCESS SYSTEMS2020-03-05
SITE-RITE 8 ULTRASOUNDBARD ACCESS SYSTEMS2020-03-05

ยฉ 2022 FDA.report
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