FDA UDI In Commercial Distribution 🇺🇸 United States

Ingenia

DI: 00884838099739 · Model: Evolution Upgrade 3.0T · Philips Medical Systems Nederland B.V.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Ingenia
Primary DI
00884838099739
Version / Model
Evolution Upgrade 3.0T
Catalog Number
782117
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
2025-10-01
Public Version
2
Public Version Date
2025-12-15
Public Version Status
Update
Public Device Record Key
0a10dea0-c83c-4863-afaa-0141e0b1c7b2

Device Description

Upgrade to the next generation portfolio for our customers having an Ingenia 3.0T

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
LNH System, Nuclear Magnetic Resonance Imaging
LNI System, Nuclear Magnetic Resonance Spectroscopic

GMDN Terms

Code Name
37654 Full-body MRI system, superconducting magnet

Identifiers

Type ID
Primary 00884838099739