Device
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 expect...
Manufacturer
SUN NUCLEAR CORP.
SUN NUCLEAR CORP.
Model: RC1000
DI: 05060608881499
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-10
Current Version: 2026-05-18
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.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
07bf25e7-f30b-4c8a-aa62-7aa3763505ed
Distribution Status:
In Commercial Distribution
DUNS Number:
122240021
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
05060608881499
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 60724
Name: Multidisciplinary medical image management software
Definition:
A software application intended to be used to receive, collect, store, and display a broad range of medical imaging and/or video data, and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching); it might be designed for holographic viewing of three-dimensional (3-D) images in conjunction with an appropriate headset or for real-time communication of diagnostic/surgical images, and might also enable the control of light settings of a device (e.g., microscope) for image acquisition.
FDA Product Codes
LHO
Instrument, Quality-Assurance, Radiologic