GE PARALLEL DESIGN, INC.

Registration Details

Registration Name: GE PARALLEL DESIGN, INC.
Registration Number: 2032350
FEI Number: 3003309342
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: 4313 E COTTON CENTER BLVD STE 100
City: PHOENIX
State: AZ
ZIP: 85040
Country: US

Regulatory Submissions

510(k) Number: K191792
PMA Number: P110006

Owner / Operator

Firm Name: GE HealthCare Technologies Inc.
Operator Number: 9912004
Address: 3000 N. Grandview Blvd
City: Waukesha
State: WI
Postal Code: 53188
Country: US

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	Class 2	Radiology	No	2019-08-20
System, Imaging, Pulsed Echo, Ultrasonic	IYO	Class 2	Radiology	No	2019-08-20
Transducer, Ultrasonic, Diagnostic	ITX	Class 2	Radiology	No	2019-08-20
Automated Radiological Image Processing Software	QIH	Class 2	Radiology	No	2026-01-05
Automated Breast Ultrasound	PAA	Class 3	Unknown	No	2013-02-11
System, Image Processing, Radiological	LLZ	Class 2	Radiology	No	2018-06-13
Catheter, Ultrasound, Intravascular	OBJ	Class 2	Cardiovascular	No	2021-03-11

Proprietary Names

12L-RS E8C-RS 6S-RS 3Sc-RS Versana Balance 8C-RS E8Cs-RS L6-12-RS 4C-RS LK760-RS RAB2-6-RS RSP6-16-D RIC10-D RM7C RAB6-D eM6C G3 IC5-9-D Voluson Expert 20 M5Sc-D Voluson Expert 22 RIC5-9-D 6S-D 9L-D RIC6-12-D RAB7-D C2-9-D 12S-D C1-6-D RM6C 11L-D RIC12-D Voluson Expert 18 ML6-15-D L8-18i-D 9L t739 ERB 11L 12L 4C E8C 10L E8CS L4-12t-RS ML6-15-RS 12S-RS M5Sc-RS Venue L4-20t-RS L12n-RS L10-22-RS C1-5-RS C2-9-RS L8-18i-RS 6Tc-RS 9L-RS Invenia ABUS Workstation Invenia ABUS Invenia ABUS Scan Station Invenia ABUS Review Software ABUS Single-Use Stabilization Membrane - non Sterile Invenia ABUS 2 Invenia ABUS Prime Invenia ABUS Premium P2D 4Vc-D Vivid S70N C3-10-D Vivid S60N C1-5-D 9T-RS 6VT-D Vivid S70N Dimension P6D RAB4-8-RS Voluson i Voluson e RAB2-5-RS RIC5-9W-RS RNA5-9-RS Versana Active RIC5-9A-RS Voluson P6 Voluson P8 IC9-RS IC9B-RS RAB6-RS Voluson SWIFT Voluson SWIFT+ Vivid T9 Vivid T8 Versana Essential iC5-9-D Vivid Pioneer 9VT-D 6Sc-D 10-D 6Vc-D 10T-D Vivid iq 6Tc Vivid S70 Vivid S60 LOGIQ E10 C1-6VN-D L2-9VN-D L2-9-D BE9CS-D C2-9VN-D LOGIQ e Venue Trident Vivid iq v206 to v208 SW only UPG Vivid iq v206 to v208 HW+SW UPG Versana Premier E7C8L-RS L3-12-RS BE9CS-RS Venue Go 9T Vivid E80 8C 4V-D Vivid E90 Vivid E95 LOGIQ Totus L3-12-D LOGIQ e NextGen NextGen LOGIQ e LOGIQ E10s R2R3 to R4 SW Upgrade W LOGIQ Fortis R3 to R4 SW Upgrade W L4-20t-D LOGIQ Fortis ML4-20VN-D LOGIQ E10s R2R3 to R4 SW Upgrade LOGIQ E10s ML4-20-D LOGIQ Fortis R3 to R4 HW Upgrade LOGIQ Fortis R3 to R4 HW Upgrade W LOGIQ E10s R2R3 to R4 HW Upgrade LOGIQ Fortis R3 to R4 SW Upgrade LOGIQ E10s R2R3 to R4 HW Upgrade W LOGIQ P9 M5sc-RS LOGIQ P10 E8CS-RS LOGIQ P8 LOGIQ P10 R4 to R4.5 UPG LOGIQ P9 R4 to R4.5 UPG LOGIQ P8 R4 to R4.5 UPG IC9-D eM6C G2 eM6C Voluson E10 RAB2-5-D Voluson E6 Voluson E8 RNA5-9-D L6-24-D Voluson E8 Expert SP10-16-D 3S-D RSM5-14 RM14L PA6-8-D RAM3-8 Probe eM6CG2 C4-8-D Voluson E series BT16 Voluson E6 BT16 Voluson E10 BT16 Voluson E series Voluson E8 BT16 Voluson S6 BT16 Voluson S10 Voluson S series Voluson S8 BT16 Voluson S8 Voluson S6 Voluson S series BT16 Voluson S10 BT16 Invenia ABUS Viewer Venue Sprint Venue Fit LOGIQ P7 Vivid T8 T9 v204 v205 to v206 UPG SW only Vivid T8 T9 v204 v205 to v206 UPG LOGIQ S20 LOGIQ S20 Express LOGIQ Vita Power LOGIQ Vita Express LOGIQ S20 Plus LOGIQ S20 Pro LOGIQ Vita Plus LOGIQ S20 Power LOGIQ Vita LOGIQ Vita Pro Vivid T8 T9 v206 to v208 SW only UPG LOGIQ E9 M6C-D 3CRF RAB4-8-D LOGIQ E9 XDClear 2 S4-10-D Voluson Performance 18 Voluson Performance 16 6S Voluson S8t Voluson S10 Expert LOGIQ F8 Expert LOGIQ F6 LOGIQ F8 LOGIQ S8 4D ICE catheter E8Cs-RS (only for Vivid T9) C1-5-RS (only for Vivid T9) P6D-RS 7S-RS 10S-RS 8L-RS LOGIQ F Versana Premier Lotus LOGIQ V2 LOGIQ V1 5CS 3S 3.5C 7S LOGIQ P5 4D3C-L ML6-15 BE9CS LOGIQ S7 Expert Voluson E series BT15 LOGIQ E10s R2 to R3 UPG LOGIQ V5 LOGIQ V5 Expert LOGIQ V3

Establishment Types

Manufacture Medical Device