Ingenia

Basic Information

• Brand Name: Ingenia
• Primary DI: 00884838099449
• Version / Model: Acoustic Hood
• Catalog Number: 989603020982
• Company Name: Philips Medical Systems Nederland B.V.
• Labeler DUNS: 413819707
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-31
• Public Version: 2
• Public Version Date: 2023-09-26
• Public Version Status: Update
• Public Device Record Key: 0b8d1ed9-0bd6-48dd-bdca-7d6d6e16bce0

Device Description

"The Achieva acoustic hood is designed to be used with the SENSE Pediatric Head Spine coil and the SENSE Pediatric Body/Cardiac coil and their mattresses. The acoustic will provide good acoustic noise damping for vulnerable neonatal patients requiring MR examinations. Premature patients are scanned while their acoustic sensory system is still in development and should be protected. Very small children will not always tolerate a headset."

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: No
• 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
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	892.1000	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37654	Full-body MRI system, superconducting magnet	A diagnostic general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body (full-body imaging). This system includes a superconducting magnet assembly and can be fixed-location, mobile, or transportable. Some systems can perform MR spectroscopy or various real-time imaging procedures for MRI guided interventional, therapeutic, or surgical applications. The system is available in a variety of system gantry configurations including closed bore, open bore, and open-sided or other kinds of patient accessible designs.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838099449	GS1

Premarket Submissions

Submission Number	Supplement Number
K193215	000
K213583	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 20 – 95 Percent (%) Relative Humidity