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Cassette

FDA UDI

Class II (US FDA UDI)

by Oxos Medical

Identity

Trade Name
Cassette FDA UDI
Generic Name
Hand-held basic diagnostic x-ray system, digital FDA UDI
Model / Reference
C1 FDA UDI

Identifiers

Primary DI / UDI-DI
00860001123418 FDA UDI
510(k) Number
K241567 FDA UDI
FDA Product Code
OWB FDA UDI
OXO FDA UDI
IZL FDA UDI
GMDN Term
Hand-held basic diagnostic x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1650 FDA UDI
892.1720 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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Hand-held basic diagnostic x-ray system, digital

Cassette by Oxos Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hand-held basic diagnostic x-ray system, digital.

Cleared under the same submission

K241567 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Oxos Medical

Sources (1)

  • FDA UDI e13fd14a-65a4-4f5a-a4f1-6bdef5b4d9c2 34 fields · synced May 30, 2026