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See Factor CT3

FDA UDI

Class II (US FDA UDI)

by Epica Human Health

Identity

Trade Name
See Factor CT3 FDA UDI
Generic Name
Cone beam computed tomography system, head/neck FDA UDI
Device Name
Mobile multimodality cone beam computed tomography scanner. FDA UDI
Model / Reference
9801101000 FDA UDI
Description
Mobile multimodality cone beam computed tomography scanner. FDA UDI

Identifiers

Primary DI / UDI-DI
00860012510900 FDA UDI
510(k) Number
K233230 FDA UDI
FDA Product Code
OWB FDA UDI
JAK FDA UDI
GMDN Term
Cone beam computed tomography system, head/neck FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1650 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

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

Category: Cone beam computed tomography system, head/neck

See Factor CT3 by Epica Human Health — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cone beam computed tomography system, head/neck.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Epica Human Health

Sources (1)

  • FDA UDI e01542b4-062b-4b0c-9042-6cb1abc19831 34 fields · synced May 30, 2026