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Genoray

FDA UDI

Class II (US FDA UDI)

by Genoray Co., Ltd.

Identity

Trade Name
Genoray FDA UDI
Generic Name
Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
Model / Reference
PAPAYA 3D FDA UDI

Identifiers

Primary DI / UDI-DI
08809244061127 FDA UDI
510(k) Number
K150354 FDA UDI
K220392 FDA UDI
FDA Product Code
MUH FDA UDI
OAS FDA UDI
GMDN Term
Stationary panoramic/tomographic dental x-ray system, digital FDA UDI

Classification

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

No

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

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

Genoray by Genoray Co., Ltd. — 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

K150354 also covers:

K220392 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Genoray Co., Ltd.

Sources (1)

  • FDA UDI 714a5504-d147-4754-9284-9d5fefa90294 33 fields · synced Jun 6, 2026