DEVICE: Ingenia (00884838088115)

Device Identifier (DI) Information

Ingenia
Ingenia Elition X
In Commercial Distribution
781358
Philips Medical Systems Nederland B.V.
00884838088115
GS1

1
413819707 *Terms of Use
Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin.
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Device Characteristics

MR Safe
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LNH System, nuclear magnetic resonance imaging
LNI System, nuclear magnetic resonance spectroscopic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K173356 000
K173451 000
K183063 000
K193215 000
K213516 000
K213583 000
K230972 000
K232030 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

6000a5d3-8134-4b6b-b5a8-62d90989d4ff
June 30, 2025
13
April 25, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(800)722-9377
xx@xx.xx
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