← Back to catalogue

Amx

FDA UDI

Class II (US FDA UDI)

by Ge Medical Systems, Inc.

Identity

Trade Name
AMX FDA UDI
Generic Name
Mobile basic diagnostic x-ray system, digital FDA UDI
Device Name
AMX Navigate Designated Medical Device Assembly FDA UDI
Model / Reference
Navigate FDA UDI
Description
AMX Navigate Designated Medical Device Assembly FDA UDI

Identifiers

Primary DI / UDI-DI
00195278003348 FDA UDI
510(k) Number
K210982 FDA UDI
FDA Product Code
IZL FDA UDI
MQB FDA UDI
GMDN Term
Mobile basic diagnostic x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1720 FDA UDI
892.1680 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Mobile basic diagnostic x-ray system, digital

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

Similar devices

Also classified as Mobile basic diagnostic x-ray system, digital.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Ge Medical Systems, Inc.

Sources (1)

  • FDA UDI fbbcf95c-ddec-4fc6-8b0a-8563e93c4c9b 34 fields · synced Jun 8, 2026