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I-Max 3d

FDA UDI

Class II (US FDA UDI)

by Owandy Radiology

Identity

Trade Name
I-MAX 3D FDA UDI
Generic Name
Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
Device Name
I-MAX 3D CEPH version FDA UDI
Model / Reference
I-MAX 3D PAN CEPH 110-120V FDA UDI
Description
I-MAX 3D CEPH version FDA UDI

Identifiers

Catalog Number
9304301011 FDA UDI
Primary DI / UDI-DI
03760262651828 FDA UDI
510(k) Number
K201382 FDA UDI
FDA Product Code
OAS FDA UDI
MUH FDA UDI
GMDN Term
Stationary panoramic/tomographic dental x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1750 FDA UDI
872.1800 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

No

FDA UDI

Category: Stationary panoramic/tomographic dental x-ray system, digital

I-Max 3d by Owandy Radiology — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary panoramic/tomographic dental x-ray system, digital.

Cleared under the same submission

K201382 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Owandy Radiology

Sources (1)

  • FDA UDI 6703087c-9db8-4102-a6ad-5f273729f995 36 fields · synced May 30, 2026