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
- [email protected]
- Phone
- 262 3092157
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2020-11-19 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2026-06-01 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2026-06-01 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2026-03-26 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2014-10-08 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2021-03-11 |
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