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TxStudio

FDA UDI

Class II (US FDA UDI)

by Anatomage, Inc.

Identity

Trade Name
TxStudio FDA UDI
Generic Name
Radiology information system application software FDA UDI
Device Name
3D imaging application specialized in dental and medical applications such as implantology, orthodontics, oral surgery, and restorative. FDA UDI
Model / Reference
6.0 FDA UDI
Description
3D imaging application specialized in dental and medical applications such as implantology, orthodontics, oral surgery, and restorative. FDA UDI

Identifiers

Primary DI / UDI-DI
00852060007037 FDA UDI
510(k) Number
K123519 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Radiology information system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Radiology information system application software

TxStudio by Anatomage, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiology information system application software.

Cleared under the same submission

K123519 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Anatomage, Inc.

Sources (1)

  • FDA UDI 0830cff4-18b1-47db-833b-67158f5b2ed0 34 fields · synced Jun 8, 2026