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Discovery

FDA UDI

Class II (US FDA UDI)

by Ge Medical Systems, Inc.

Identity

Trade Name
Discovery FDA UDI
Generic Name
Full-body CT system FDA UDI
Device Name
PET DMI Gen2 Image System Asm, No Detectors Installed, Common Weld Gantry, Manufacturing Make FDA UDI
Model / Reference
MI FDA UDI
Description
PET DMI Gen2 Image System Asm, No Detectors Installed, Common Weld Gantry, Manufacturing Make FDA UDI

Identifiers

Primary DI / UDI-DI
00195278098603 FDA UDI
510(k) Number
K161574 FDA UDI
FDA Product Code
JAK FDA UDI
KPS FDA UDI
GMDN Term
Full-body CT system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1750 FDA UDI
892.1200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Full-body CT systemPET system

Discovery by Ge Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as PET system.

Cleared under the same submission

K161574 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ge Medical Systems, Inc.

Sources (1)

  • FDA UDI 89250495-f71c-489f-9797-ac7c856202b1 34 fields · synced May 30, 2026