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Aline Ablation Intelligence

FDA UDI

Class II (US FDA UDI)

by Mirada Medical, Ltd.

Identity

Trade Name
Aline Ablation Intelligence FDA UDI
Generic Name
Radiology picture archiving and communication system workstation FDA UDI
Model / Reference
1.0 FDA UDI

Identifiers

Primary DI / UDI-DI
B334ALINE1P00 FDA UDI
510(k) Number
K202297 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Radiology picture archiving and communication system workstation FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radiology picture archiving and communication system workstation

Aline Ablation Intelligence by Mirada Medical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiology picture archiving and communication system workstation.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mirada Medical, Ltd.

Sources (1)

  • FDA UDI 72838260-634e-450f-ab41-725f0d6a7c31 34 fields · synced Jun 1, 2026