Device
A picture archiving and communication system software that retrieves, archive, distributes, and displays images and data from all common modalities.
Manufacturer
Novarad Corporation
Novarad Corporation
Model: NovaPACS 9.1.6
DI: B109NOVAPACS9160
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-21
Current Version: 2026-05-29
Description
A picture archiving and communication system software that retrieves, archive, distributes, and displays images and data from all common modalities.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
5c0ebdac-67e3-46ea-ab75-6b5156ab18f1
Distribution Status:
In Commercial Distribution
DUNS Number:
071991843
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
B109NOVAPACS9160
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 41670
Name: Radiological PACS software
Definition:
An individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.
FDA Product Codes
LLZ
System, Image Processing, Radiological
Premarket Submissions
Submission Number:
K171754
Supplement Number:
000