FDA Registration Active 🇫🇷 France

PARALLEL DESIGN SAS

Reg #: 3003594449 · FEI: 3003594449 · Expires 2026
Products
6
Proprietary Names
200
Establishment Types
1
Classifications
6

Registration Details

Registration Name
PARALLEL DESIGN SAS
Registration Number
3003594449
FEI Number
3003594449
Status
Active
Expiry Year
2026
Initial Importer
No
Address
1090 Route des Cretes
City
VALBONNE
Country
FR

Regulatory Submissions

510(k) Number
K173957

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

US Agent

Business Name
GE HealthCare Technologies, Inc
Contact Name
Tracey Holevas
Address
3000 N. Grandview BLVD
City
Waukesha
State
WI
ZIP
53188
Country
US
Phone
262 3092157

Products

Device Name Product Code
Transducer, Ultrasonic, Diagnostic ITX
System, Imaging, Pulsed Echo, Ultrasonic IYO
System, Imaging, Pulsed Doppler, Ultrasonic IYN
Automated Radiological Image Processing Software QIH
Catheter, Intravascular, Diagnostic DQO
Catheter, Ultrasound, Intravascular OBJ

Proprietary Names

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

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility