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RapidCheck

FDA UDI

Class I (US FDA UDI)

by Sun Nuclear Corporation

Identity

Trade Name
RapidCheck FDA UDI
Generic Name
Multidisciplinary medical image management software FDA UDI
Device Name
The RapidCHECK platform is intended for supporting users in analyzing diagnostic imaging data to ensure the performance of the diagnostic system is operating within safe and expected tolerances. FDA UDI
Model / Reference
RC1000 FDA UDI
Description
The RapidCHECK platform is intended for supporting users in analyzing diagnostic imaging data to ensure the performance of the diagnostic system is operating within safe and expected tolerances. FDA UDI

Identifiers

Primary DI / UDI-DI
B136RC10000 FDA UDI
FDA Product Code
LHO FDA UDI
GMDN Term
Multidisciplinary medical image management software FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.1940 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multidisciplinary medical image management software

RapidCheck by Sun Nuclear Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multidisciplinary medical image management software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sun Nuclear Corporation

Sources (1)

  • FDA UDI ccbf4c53-df67-4eca-bcb1-f0e577631f2a 34 fields · synced Jun 8, 2026