Advanced Ultrasound Electronics

FDA Filings

This page includes the latest FDA filings for Advanced Ultrasound Electronics. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3012385618
• FEI Number: 3012385618
• Name: ADVANCED ULTRASOUND ELECTRONICS
• Owner & Operator: Advanced Ultrasound Electronics
• Contact Address: 9522 E 47th Pl Suite C; Tulsa OK 74145 US
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 9522 E 47th Pl Suite C; Tulsa, OK 74145 US
• Establishment Type: Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
PMN K131937 | IYO ADVANCED ULTRASOUND ELECTRONICS	Voluson i, e and probes: 1C5-9W-RS, RAB2-6-RS, 8C-RS, 9L-RS, RAB4-8-RS, RIC5-9W-RS, RNA5-9-RS, AB2-7-RS, SP10-16-RS	2019-11-22
PMN K131937 | IYN ADVANCED ULTRASOUND ELECTRONICS	Voluson i, e and probes: 1C5-9W-RS, RAB2-6-RS, 8C-RS, 9L-RS, RAB4-8-RS, RIC5-9W-RS, RNA5-9-RS, AB2-7-RS, SP10-16-RS	2019-11-22
PMN K131937 | ITX ADVANCED ULTRASOUND ELECTRONICS	Voluson i, e and probes: 1C5-9W-RS, RAB2-6-RS, 8C-RS, 9L-RS, RAB4-8-RS, RIC5-9W-RS, RNA5-9-RS, AB2-7-RS, SP10-16-RS	2019-11-22
PMN K143027 | IYO ADVANCED ULTRASOUND ELECTRONICS	Toshiba Xario 100, Xario 200 and probes: PLU-704BT,PVU-375BT,PSU-30BT	2019-08-12
PMN K143027 | IYN ADVANCED ULTRASOUND ELECTRONICS	Toshiba Xario 100, Xario 200 and probes: PLU-704BT,PVU-375BT,PSU-30BT	2019-08-12
PMN K143027 | ITX ADVANCED ULTRASOUND ELECTRONICS	Toshiba Xario 100, Xario 200 and probes: PLU-704BT,PVU-375BT,PSU-30BT	2019-08-12
PMN K162902 | IYO ADVANCED ULTRASOUND ELECTRONICS	Hitachi Arietta Prologue and probes: S211, C22P, C251, C25P, C35, C41B, C41V1, C42K, L44, L441 +	2019-06-18
PMN K162902 | IYN ADVANCED ULTRASOUND ELECTRONICS	Hitachi Arietta Prologue and probes: S211, C22P, C251, C25P, C35, C41B, C41V1, C42K, L44, L441 +	2019-06-18
PMN K162902 | ITX ADVANCED ULTRASOUND ELECTRONICS	Hitachi Arietta Prologue and probes: S211, C22P, C251, C25P, C35, C41B, C41V1, C42K, L44, L441 +	2019-06-18
PMN K142368 | IYO ADVANCED ULTRASOUND ELECTRONICS	Hitachi Noblus with probes: S211, S31, C35, C41, C41V, C42, EUP-L74M, C251, L55, L441, EUP-L53L	2019-06-18
PMN K142368 | IYN ADVANCED ULTRASOUND ELECTRONICS	Hitachi Noblus with probes: S211, S31, C35, C41, C41V, C42, EUP-L74M, C251, L55, L441, EUP-L53L	2019-06-18
PMN K142368 | ITX ADVANCED ULTRASOUND ELECTRONICS	Hitachi Noblus with probes: S211, S31, C35, C41, C41V, C42, EUP-L74M, C251, L55, L441, EUP-L53L	2019-06-18
PMN K120703 | IYO ADVANCED ULTRASOUND ELECTRONICS	Zonare ZS3 & probes: C4-1, C6-2, C9-3, C10-3, L10-5, C9-4t, P4-1c, P10-4, E9-4, L8-3, L12-4, L14-5, P8-3,	2019-03-15
PMN K120703 | IYN ADVANCED ULTRASOUND ELECTRONICS	Zonare ZS3 & probes: C4-1, C6-2, C9-3, C10-3, L10-5, C9-4t, P4-1c, P10-4, E9-4, L8-3, L12-4, L14-5, P8-3,	2019-03-15
PMN K120703 | ITX ADVANCED ULTRASOUND ELECTRONICS	Zonare ZS3 & probes: C4-1, C6-2, C9-3, C10-3, L10-5, C9-4t, P4-1c, P10-4, E9-4, L8-3, L12-4, L14-5, P8-3,	2019-03-15
PMN K041916 | IYO ADVANCED ULTRASOUND ELECTRONICS	Aloka Alpha 5 and probes: UST-5410, UST-9128, UST-9118, UST-52101, UST-9126, UST-52108	2019-01-11
PMN K041916 | IYN ADVANCED ULTRASOUND ELECTRONICS	Aloka Alpha 5 and probes: UST-5410, UST-9128, UST-9118, UST-52101, UST-9126, UST-52108	2019-01-11
PMN K041916 | ITX ADVANCED ULTRASOUND ELECTRONICS	Aloka Alpha 5 and probes: UST-5410, UST-9128, UST-9118, UST-52101, UST-9126, UST-52108	2019-01-11
PMN K151028 | IYO ADVANCED ULTRASOUND ELECTRONICS	Parts for GE Logiq e and -RS transducers	2019-01-10
PMN K151028 | IYO ADVANCED ULTRASOUND ELECTRONICS	GE Logiq e, C1-5-RS, 4C-RS, 8C-RS, E8C-RS, 9L-RS, 12L-RS, L4-12t-RS, L8-18i-RS, L10-22-RS, 3Sc-RS, LK760-RS, 6S-RS, 6Tc-	2019-01-10
PMN K151028 | IYN ADVANCED ULTRASOUND ELECTRONICS	Parts for GE Logiq e and -RS transducers	2019-01-10
PMN K151028 | IYN ADVANCED ULTRASOUND ELECTRONICS	GE Logiq e, C1-5-RS, 4C-RS, 8C-RS, E8C-RS, 9L-RS, 12L-RS, L4-12t-RS, L8-18i-RS, L10-22-RS, 3Sc-RS, LK760-RS, 6S-RS, 6Tc-	2019-01-10
PMN K151028 | ITX ADVANCED ULTRASOUND ELECTRONICS	Parts for GE Logiq e and -RS transducers	2019-01-10
PMN K151028 | ITX ADVANCED ULTRASOUND ELECTRONICS	GE Logiq e, C1-5-RS, 4C-RS, 8C-RS, E8C-RS, 9L-RS, 12L-RS, L4-12t-RS, L8-18i-RS, L10-22-RS, 3Sc-RS, LK760-RS, 6S-RS, 6Tc-	2019-01-10
PMN K100067 | IYO ADVANCED ULTRASOUND ELECTRONICS	Toshiba Viamo & transducers: PLT-704AT, PVT-674BT, PLT-704ST, PVT-705BTH, PLT-1204BT, PVT-375ST, PVT-745BTV, PVT-382BT,	2018-12-18
PMN K100067 | IYN ADVANCED ULTRASOUND ELECTRONICS	Toshiba Viamo & transducers: PLT-704AT, PVT-674BT, PLT-704ST, PVT-705BTH, PLT-1204BT, PVT-375ST, PVT-745BTV, PVT-382BT,	2018-12-18
PMN K100067 | ITX ADVANCED ULTRASOUND ELECTRONICS	Toshiba Viamo & transducers: PLT-704AT, PVT-674BT, PLT-704ST, PVT-705BTH, PLT-1204BT, PVT-375ST, PVT-745BTV, PVT-382BT,	2018-12-18
PMN K153626 | IYO ADVANCED ULTRASOUND ELECTRONICS	Edge II & transducers:C11x/8-5, rC60xi/5-2, HFL38xi/13-6, HFL50x/15-6, HSL25x/13-6, ICTx/8-5, L25x/13-6, L38xi/10-5, P10	2018-12-17
PMN K153626 | IYN ADVANCED ULTRASOUND ELECTRONICS	Edge II & transducers:C11x/8-5, rC60xi/5-2, HFL38xi/13-6, HFL50x/15-6, HSL25x/13-6, ICTx/8-5, L25x/13-6, L38xi/10-5, P10	2018-12-17
PMN K153626 | ITX ADVANCED ULTRASOUND ELECTRONICS	Edge II & transducers:C11x/8-5, rC60xi/5-2, HFL38xi/13-6, HFL50x/15-6, HSL25x/13-6, ICTx/8-5, L25x/13-6, L38xi/10-5, P10	2018-12-17
PMN K132804 | OBJ ADVANCED ULTRASOUND ELECTRONICS	S1000, S2000, S3000 & transducers; CW2 CW5 MC9-4 9L-4 14L5 4P1 6C2 4C1 6C1HD 8C3HD 4V1 10V414L5SP 7CF2 7CF1 9EVF4 8V3	2018-10-24
PMN K132804 | IYO ADVANCED ULTRASOUND ELECTRONICS	S1000, S2000, S3000 & transducers; CW2 CW5 MC9-4 9L-4 14L5 4P1 6C2 4C1 6C1HD 8C3HD 4V1 10V414L5SP 7CF2 7CF1 9EVF4 8V3	2018-10-24
PMN K132804 | IYN ADVANCED ULTRASOUND ELECTRONICS	S1000, S2000, S3000 & transducers; CW2 CW5 MC9-4 9L-4 14L5 4P1 6C2 4C1 6C1HD 8C3HD 4V1 10V414L5SP 7CF2 7CF1 9EVF4 8V3	2018-10-24
PMN K132804 | ITX ADVANCED ULTRASOUND ELECTRONICS	S1000, S2000, S3000 & transducers; CW2 CW5 MC9-4 9L-4 14L5 4P1 6C2 4C1 6C1HD 8C3HD 4V1 10V414L5SP 7CF2 7CF1 9EVF4 8V3	2018-10-24
PMN K081802 | IYO ADVANCED ULTRASOUND ELECTRONICS	Philips CX50 & CX30 with transducers: S5-1, X7-2t, D2cwc	2018-09-10
PMN K081802 | IYN ADVANCED ULTRASOUND ELECTRONICS	Philips CX50 & CX30 with transducers: S5-1, X7-2t, D2cwc	2018-09-10
PMN K081802 | ITX ADVANCED ULTRASOUND ELECTRONICS	Philips CX50 & CX30 with transducers: S5-1, X7-2t, D2cwc	2018-09-10
PMN K081154 | IYO ADVANCED ULTRASOUND ELECTRONICS	B-K Medical FlexFocus 1202, FlexFocus 400, FlexFocus 500, FlexFocus 800 with probes 8661, 8662, 8811, 8820, 8827, 8539,	2018-09-04
PMN K081154 | IYN ADVANCED ULTRASOUND ELECTRONICS	B-K Medical FlexFocus 1202, FlexFocus 400, FlexFocus 500, FlexFocus 800 with probes 8661, 8662, 8811, 8820, 8827, 8539,	2018-09-04
PMN K081154 | ITX ADVANCED ULTRASOUND ELECTRONICS	B-K Medical FlexFocus 1202, FlexFocus 400, FlexFocus 500, FlexFocus 800 with probes 8661, 8662, 8811, 8820, 8827, 8539,	2018-09-04
PMN K103649 | IYO ADVANCED ULTRASOUND ELECTRONICS	GE Voluson S8, S6, and transducers; RAB4-8-RS, 4C-RS, E8C-RS, CI-5-RS, 12L-RS, AB2-7-RS, RIC5-9W-RS.	2018-08-28
PMN K103649 | IYN ADVANCED ULTRASOUND ELECTRONICS	GE Voluson S8, S6, and transducers; RAB4-8-RS, 4C-RS, E8C-RS, CI-5-RS, 12L-RS, AB2-7-RS, RIC5-9W-RS.	2018-08-28
PMN K103649 | ITX ADVANCED ULTRASOUND ELECTRONICS	GE Voluson S8, S6, and transducers; RAB4-8-RS, 4C-RS, E8C-RS, CI-5-RS, 12L-RS, AB2-7-RS, RIC5-9W-RS.	2018-08-28
PMN K042540 | IYO ADVANCED ULTRASOUND ELECTRONICS	Philips iU22 and iE33, X3-1, S5-1	2018-08-19
PMN K042540 | IYN ADVANCED ULTRASOUND ELECTRONICS	Philips iU22 and iE33, X3-1, S5-1	2018-08-19
PMN K042540 | ITX ADVANCED ULTRASOUND ELECTRONICS	Philips iU22 and iE33, X3-1, S5-1	2018-08-19
PMN K072285 | IYO ADVANCED ULTRASOUND ELECTRONICS	Alojka Alpha 7	2018-07-25
PMN K072285 | IYN ADVANCED ULTRASOUND ELECTRONICS	Alojka Alpha 7	2018-07-25
PMN K072285 | ITX ADVANCED ULTRASOUND ELECTRONICS	Alojka Alpha 7	2018-07-25
PMN K122387 | IYO ADVANCED ULTRASOUND ELECTRONICS	GE Voluson P6, P8	2018-07-24
PMN K122387 | IYN ADVANCED ULTRASOUND ELECTRONICS	GE Voluson P6, P8	2018-07-24
PMN K122387 | ITX ADVANCED ULTRASOUND ELECTRONICS	GE Voluson P6, P8	2018-07-24
PMN K121422 | IYO ADVANCED ULTRASOUND ELECTRONICS	Toshiba Aplio 300, 400, 500	2018-07-24
PMN K121422 | IYO ADVANCED ULTRASOUND ELECTRONICS	Toshiba Aplio 300, 400, 500 with probes: PVT-375BT PVT-712BT PLT-705BTF PVT-375MV PVT-745BTF PVT-705BTH PET-512MC	2018-07-24
PMN K121422 | IYN ADVANCED ULTRASOUND ELECTRONICS	Toshiba Aplio 300, 400, 500	2018-07-24
PMN K121422 | IYN ADVANCED ULTRASOUND ELECTRONICS	Toshiba Aplio 300, 400, 500 with probes: PVT-375BT PVT-712BT PLT-705BTF PVT-375MV PVT-745BTF PVT-705BTH PET-512MC	2018-07-24
PMN K121422 | ITX ADVANCED ULTRASOUND ELECTRONICS	Toshiba Aplio 300, 400, 500	2018-07-24
PMN K121422 | ITX ADVANCED ULTRASOUND ELECTRONICS	Toshiba Aplio 300, 400, 500 with probes: PVT-375BT PVT-712BT PLT-705BTF PVT-375MV PVT-745BTF PVT-705BTH PET-512MC	2018-07-24
PMN K112213 | IYO ADVANCED ULTRASOUND ELECTRONICS	GE Voluson E8, E6	2018-07-24
PMN K112213 | IYN ADVANCED ULTRASOUND ELECTRONICS	GE Voluson E8, E6	2018-07-24
PMN K112213 | ITX ADVANCED ULTRASOUND ELECTRONICS	GE Voluson E8, E6	2018-07-24
PMN K082374 | IYO ADVANCED ULTRASOUND ELECTRONICS	Vivid i and q, and many -RS probes	2018-07-24
PMN K082374 | IYN ADVANCED ULTRASOUND ELECTRONICS	Vivid i and q, and many -RS probes	2018-07-24
PMN K082374 | ITX ADVANCED ULTRASOUND ELECTRONICS	Vivid i and q, and many -RS probes	2018-07-24
PMN K081921 | IYN ADVANCED ULTRASOUND ELECTRONICS	GE Vviid E9 system	2018-07-24
PMN K042833 | IYO ADVANCED ULTRASOUND ELECTRONICS	Siemens G20	2018-07-24
PMN K042833 | ITX ADVANCED ULTRASOUND ELECTRONICS	Siemens G20	2018-07-24
PMN K032135 | IYO ADVANCED ULTRASOUND ELECTRONICS	Dymax (Bard) Site-Rite IV	2018-07-24
PMN K032135 | ITX ADVANCED ULTRASOUND ELECTRONICS	Dymax (Bard) Site-Rite IV	2018-07-24
PMN K131164 | OBJ ADVANCED ULTRASOUND ELECTRONICS	Siemens Acuson S2000, S3000	2018-07-18
PMN K131164 | IYO ADVANCED ULTRASOUND ELECTRONICS	Siemens Acuson S2000, S3000	2018-07-18
PMN K131164 | IYN ADVANCED ULTRASOUND ELECTRONICS	Siemens Acuson S2000, S3000	2018-07-18
PMN K131164 | ITX ADVANCED ULTRASOUND ELECTRONICS	Siemens Acuson S2000, S3000	2018-07-18
PMN K072676 | IYO ADVANCED ULTRASOUND ELECTRONICS	Siemens X300	2018-07-18
PMN K072676 | IYN ADVANCED ULTRASOUND ELECTRONICS	Siemens X300	2018-07-18
PMN K072676 | ITX ADVANCED ULTRASOUND ELECTRONICS	Siemens X300	2018-07-18
PMN K072676 | DQO ADVANCED ULTRASOUND ELECTRONICS	Siemens X300	2018-07-18
PMN K070576 | IYO ADVANCED ULTRASOUND ELECTRONICS	Siemens X150	2018-07-18
PMN K070576 | IYN ADVANCED ULTRASOUND ELECTRONICS	Siemens X150	2018-07-18
PMN K070576 | ITX ADVANCED ULTRASOUND ELECTRONICS	Siemens X150	2018-07-18
PMN K063803 | IYO ADVANCED ULTRASOUND ELECTRONICS	Siemens Antares	2018-07-18
PMN K063803 | IYN ADVANCED ULTRASOUND ELECTRONICS	Siemens Antares	2018-07-18
PMN K063803 | ITX ADVANCED ULTRASOUND ELECTRONICS	Siemens Antares	2018-07-18
PMN K022567 | IYO ADVANCED ULTRASOUND ELECTRONICS	Acuson Sequoia	2018-07-18
PMN K022567 | IYN ADVANCED ULTRASOUND ELECTRONICS	Acuson Sequoia	2018-07-18
PMN K022567 | ITX ADVANCED ULTRASOUND ELECTRONICS	Acuson Sequoia	2018-07-18
PMN K002470 | IYO ADVANCED ULTRASOUND ELECTRONICS	HP/ Agilent/ Philips Sonos 5500 and 4500	2018-07-18
PMN K002470 | IYN ADVANCED ULTRASOUND ELECTRONICS	HP/ Agilent/ Philips Sonos 5500 and 4500	2018-07-18
PMN K132304 | IYO ADVANCED ULTRASOUND ELECTRONICS	Philips Epiq system, parts and probes	2018-06-14
PMN K132304 | IYN ADVANCED ULTRASOUND ELECTRONICS	Philips Epiq system, parts and probes	2018-06-14
PMN K132304 | ITX ADVANCED ULTRASOUND ELECTRONICS	Philips Epiq system, parts and probes	2018-06-14
PMN K113156 | LLZ ADVANCED ULTRASOUND ELECTRONICS	SonoSite Edge, C60x/5-2, HFL38x/13-6, L38xi/10-5, HFL50x/15-6, L25X/13-6, P21x/5-1	2018-04-16
PMN K113156 | IYO ADVANCED ULTRASOUND ELECTRONICS	SonoSite Edge, C60x/5-2, HFL38x/13-6, L38xi/10-5, HFL50x/15-6, L25X/13-6, P21x/5-1	2018-04-16
PMN K113156 | IYN ADVANCED ULTRASOUND ELECTRONICS	SonoSite Edge, C60x/5-2, HFL38x/13-6, L38xi/10-5, HFL50x/15-6, L25X/13-6, P21x/5-1	2018-04-16
PMN K113156 | ITX ADVANCED ULTRASOUND ELECTRONICS	SonoSite Edge, C60x/5-2, HFL38x/13-6, L38xi/10-5, HFL50x/15-6, L25X/13-6, P21x/5-1	2018-04-16
PMN K130173 | LLZ ADVANCED ULTRASOUND ELECTRONICS	SonoSite Maxx, S Series, M-Turbo	2018-04-09
PMN K130173 | IYO ADVANCED ULTRASOUND ELECTRONICS	SonoSite Maxx, S Series, M-Turbo	2018-04-09
PMN K130173 | IYN ADVANCED ULTRASOUND ELECTRONICS	SonoSite Maxx, S Series, M-Turbo	2018-04-09
PMN K130173 | ITX ADVANCED ULTRASOUND ELECTRONICS	SonoSite Maxx, S Series, M-Turbo	2018-04-09

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018080838691	London,United Kingdom -> Houston, Texas	OF MEDICAL EQUIPMENTS CONTAINING OF MEDICAL EQUIPMENTS LOADED ON 10 PALLETS HS CODE 90181200	55 PCS