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Owandy Radiology

FDA UDI

Class II (US FDA UDI)

by Owandy Radiology

Identity

Trade Name
Owandy Radiology FDA UDI
Generic Name
Digital imaging cassette/storage phosphor screen, dental FDA UDI
Device Name
Owandy-CR V2 USB FDA UDI
Model / Reference
Owandy-CR FDA UDI
Description
Owandy-CR V2 USB FDA UDI

Identifiers

Catalog Number
9458900021 FDA UDI
Primary DI / UDI-DI
03760262652337 FDA UDI
510(k) Number
K133271 FDA UDI
K143703 FDA UDI
FDA Product Code
MUH FDA UDI
GMDN Term
Digital imaging cassette/storage phosphor screen, dental FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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: Digital imaging cassette/storage phosphor screen, dental

Owandy Radiology by Owandy Radiology — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Digital imaging cassette/storage phosphor screen, dental.

Cleared under the same submission

K133271 also covers:

K143703 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 9390ac77-a4cb-4e4e-b8ce-4b5e209a42f2 35 fields · synced May 30, 2026