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VEA Align

FDA UDI

Class II (US FDA UDI)

by Eos Imaging, Inc.

Identity

Trade Name
VEA Align FDA UDI
Generic Name
Basic diagnostic x-ray system application software FDA UDI
Model / Reference
2.1 FDA UDI

Identifiers

Primary DI / UDI-DI
03663999000337 FDA UDI
510(k) Number
K240582 FDA UDI
FDA Product Code
QIH FDA UDI
GMDN Term
Basic diagnostic x-ray system application software 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

No

FDA UDI

Category: Basic diagnostic x-ray system application software

VEA Align by Eos Imaging, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Basic diagnostic x-ray system application software.

Cleared under the same submission

K240582 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Eos Imaging, Inc.

Sources (1)

  • FDA UDI 0f0b1c88-b666-493f-b560-7351f080824b 33 fields · synced Jun 1, 2026