Revolution CT

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref 5595000-61Model Revolution

by GE Medical Systems, LLC

Identity

Trade Name: Revolution CT EUDAMED
Revolution FDA UDI
Generic Name: Full-body CT system FDA UDI
Device Name: Revolution CT - Designated System Medical Device FDA UDI
Model / Reference: Revolution EUDAMED
5595000-61 EUDAMED
CT FDA UDI
Description: Revolution CT - Designated System Medical Device FDA UDI

Identifiers

Catalog Number: 5590000-6 FDA UDI
Primary DI / UDI-DI: 00840682118552 EUDAMEDFDA UDI
Basic UDI-DI: 8406821BUG00014GP EUDAMED
510(k) Number: K093581 FDA UDI
K133705 FDA UDI
FDA Product Code: JAK FDA UDI
EMDN Code: Z11030607 COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE EUDAMED
GMDN Term: Full-body CT system FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 892.1750 FDA UDI
Market of Registration: Denmark EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Revolution CT is a computed tomography scanner manufactured by GE Medical Systems, LLC. It is a Class IIb medical device with model number Revolution and reference 5595000-61. The device is designed for measuring functions in medical imaging applications.

The Revolution CT is not sterile, not implantable, and is not reusable. It is supplied with basic UDI 8406821BUG00014GP and has authorizations including FDA 510K and MDR. The device is subject to standard device criteria and is currently active in the market.

Frequently asked questions

What is the Revolution CT scanner used for?

The Revolution CT is a computed tomography scanner designed for measuring functions in medical imaging applications. It is a Class IIb medical device that provides detailed imaging for diagnostic purposes in clinical settings.

Is the Revolution CT scanner reusable or sterile?

The Revolution CT scanner is not reusable and not sterile. It is supplied with basic UDI 8406821BUG00014GP and is designed for single-use applications in medical imaging environments.

What are the regulatory authorizations for the Revolution CT scanner?

The Revolution CT scanner has FDA 510K and MDR authorizations. It is subject to standard device criteria and is currently active in the market with model number Revolution and reference 5595000-61.

How is the Revolution CT scanner supplied?

The Revolution CT scanner is supplied with basic UDI 8406821BUG00014GP and has a unique device identifier (UDI) data ULID of 01GTYMQRRGVXMZ6GWKESKPX6JK. It is manufactured by GE Medical Systems, LLC.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: GE HealthCare recalls 24 Revolution Apex CT systems over cybersecurity ..., GE Medical Systems, LLC recalls Revolution CT, x-ray computed ..., GE REVOLUTION CT USER MANUAL Pdf Download | ManualsLib, Revolution CT Recall Issued by GE Medical Systems Over Security ...

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K163213	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K133705	Class IIb	Active
EUDAMED	European Union	CE/MDR	8406821BUG00014GP	Class IIb	Active

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Manufacturer

Manufacturer: GE Medical Systems, LLC
EUDAMED SRN: US-MF-000018315
Authorised Representative: GE Medical Systems SCS FR-AR-000000344

Sources (3)

EUDAMED feb13093-5a7c-40e5-8567-20fefac4307b 61 fields · synced Sep 21, 2026
FDA UDI fd2d5261-b298-47f7-9e24-b56ebe9de09e 35 fields · synced May 29, 2026
FDA 510(k) K163213 1 fields · synced May 18, 2026