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Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad

FDA UDI

Class II (US FDA UDI)

by Konica Minolta Medical Imaging U.s.a., Inc.

Identity

Trade Name
Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad FDA UDI
Generic Name
Diagnostic x-ray digital imaging system workstation FDA UDI
Device Name
Opal-RAD is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. FDA UDI
Model / Reference
OPAL 02-04-04-000 FDA UDI
Description
Opal-RAD is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. FDA UDI

Identifiers

Primary DI / UDI-DI
00817100020209 FDA UDI
FDA Product Code
KPR FDA UDI
GMDN Term
Diagnostic x-ray digital imaging system workstation FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1680 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Diagnostic x-ray digital imaging system workstation

Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad by Konica Minolta Medical Imaging U.s.a., Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Diagnostic x-ray digital imaging system workstation.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Konica Minolta Medical Imaging U.s.a., Inc.

Sources (1)

  • FDA UDI aa8e80b6-c2d5-458c-b7f4-f304bc10f179 34 fields · synced May 31, 2026