Model: 2.13
DI: 08437021722093
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
fec2f469-54da-44f2-abb1-4a7a4a5f921c
Distribution Status:
In Commercial Distribution
DUNS Number:
469095791
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
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:
08437021722093
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 61486
Name: Surgical simulation system
Definition:
A mobile computerized assembly of mains electricity (AC-powered) devices intended to collect and manipulate medical imaging [e.g., computed tomography (CT), magnetic resonance imaging (MRI)] data to create a patient-specific, virtual, three-dimensional (3-D), interactive model to enable a surgeon to simulate, rehearse, and plan a surgical procedure (e.g., cranial) prior to surgery. It includes dedicated software, and dedicated and/or off-the-shelf hardware such as a cart, a personal computer (PC), monitors, 3-D glasses, and a controller to simulate surgical devices and perform measurements. It is capable of collecting patient demographics, which may be anonymised.
FDA Product Codes
LLZ
System, Image Processing, Radiological
QIH
Automated Radiological Image Processing Software
Premarket Submissions
Submission Number:
K240791
Supplement Number:
000