NA

Basic Information

• Brand Name: NA
• Primary DI: 00840682107174
• Version / Model: i12L-RS
• Company Name: GE PARALLEL DESIGN, INC.
• Labeler DUNS: 623906971
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-15
• Public Version: 5
• Public Version Date: 2019-01-17
• Public Version Status: Update
• Public Device Record Key: cb410b38-1092-4b38-b2f5-f221cf02f073

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYO	System, imaging, pulsed echo, ultrasonic	Radiology	892.1560	2
LLZ	System, image processing, radiological	Radiology	892.2050	2
ITX	Transducer, ultrasonic, diagnostic	Radiology	892.1570	2
IYN	System, imaging, pulsed doppler, ultrasonic	Radiology	892.1550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40770	Surgical ultrasound imaging transducer	A hand-held ultrasound imaging transducer assembly designed to be positioned within a surgical site for localized intraoperative imaging applications. It is sometimes referred to as a surgical probe or fingertip probe. It steers, focuses, and detects the ultrasound beam and resulting echoes either mechanically or electronically. This group of devices includes ultrasound imaging transducer assemblies used with A-mode, B-mode, M-mode, Doppler, colour Doppler (CD), and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840682107174	GS1

Premarket Submissions

Submission Number	Supplement Number
K121063	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 0 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 0 – 95 Percent (%) Relative Humidity