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Intraskan Dc

FDA UDI

Class II (US FDA UDI)

by ImageWorks

Identity

Trade Name
INTRASKAN DC FDA UDI
Generic Name
Stationary intraoral dental x-ray system, digital FDA UDI
Device Name
INTRASKAN DC WITH 24" EXTENSION ARM FDA UDI
Model / Reference
9992720100 FDA UDI
Description
INTRASKAN DC WITH 24" EXTENSION ARM FDA UDI

Identifiers

Catalog Number
9992720100 FDA UDI
Primary DI / UDI-DI
D83399927201000 FDA UDI
510(k) Number
K103579 FDA UDI
FDA Product Code
EHD FDA UDI
GMDN Term
Stationary intraoral dental x-ray system, digital 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

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 intraoral dental x-ray system, digital

Intraskan Dc by ImageWorks — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary intraoral dental x-ray system, digital.

Cleared under the same submission

K103579 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ImageWorks

Sources (1)

  • FDA UDI e2be9bc5-9b19-472f-ab29-d4ae5ea793a3 35 fields · synced May 30, 2026