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TigerView

FDA UDI

Class II (US FDA UDI)

by Televere Systems

Identity

Trade Name
TigerView FDA UDI
Generic Name
Basic diagnostic x-ray system application software FDA UDI
Device Name
TigerView 8.1 software Build 81 FDA UDI
Model / Reference
8.1 Build 81 FDA UDI
Description
TigerView 8.1 software Build 81 FDA UDI

Identifiers

Catalog Number
TigerView 8.1 Build 81 FDA UDI
Primary DI / UDI-DI
00851800007016 FDA UDI
510(k) Number
K061035 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Basic diagnostic x-ray 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: Radiological PACS softwareBasic diagnostic x-ray system application softwareGeneral-purpose dental x-ray system application softwareCamera application software

TigerView by Televere Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multidisciplinary medical image management software.

Cleared under the same submission

K061035 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Televere Systems

Sources (1)

  • FDA UDI 435d1c08-a8a7-44b7-93fe-1e5be15dd8d1 36 fields · synced Jun 8, 2026