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Solero

FDA UDI

Class II (US FDA UDI)

by Angiodynamics, Inc

Identity

Trade Name
Solero FDA UDI
Generic Name
Microwave hyperthermia system FDA UDI
Device Name
MTA System FDA UDI
Model / Reference
12740000US FDA UDI
Description
MTA System FDA UDI

Identifiers

Primary DI / UDI-DI
H78712740000US0 FDA UDI
510(k) Number
K162449 FDA UDI
FDA Product Code
NEY FDA UDI
GMDN Term
Microwave hyperthermia system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Microwave hyperthermia system

Solero by Angiodynamics, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Microwave hyperthermia system.

Cleared under the same submission

K162449 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Angiodynamics, Inc

Sources (1)

  • FDA UDI aa8423ec-acb0-4b98-bc9e-2d7c4f10f44b 36 fields · synced Jun 20, 2026