Use Instructions
PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 13 of 101
The Eagle V1.2 Imaging System has received the following authorizations in order to conduct clinical trial
SBI-CIP-20-002 in accordance with applicable United States and Canadian regulatory requirements per
FDA and Health Canada:
Table 1 Investigational Authorizations
Investigational
Product
USA Canada
Drug Product:
PD G 506 A
In accordance with
21 CFR PART 312
INVESTIGATIONAL NEW DRUG
APPLICATION, an IND was submitted to
the FDA to approve PD G 506 A drug use
in clinical trial SBI-CIP 20-002
In accordance with Guidance Document for
Clinical Trial Sponsors: Clinical Trial
Applications a CTA was submitted to Health
Canada to approve PD G 506 A drug use in
clinical trial SBI-CIP 20-002
Imaging Device:
Eagle V1.2
Imaging System
In accordance with
21 CFR PART 812
INVESTIGATIONAL DEVICE EXEMPTIONS,
an IDE is not required to approve Eagle
V1.2 Imaging System for use in clinical
trial SBI-CIP 20-002
In accordance with Guidance Document
Applications for Medical Device
Investigational Testing Authorizations an
ITA was submitted to Health Canada to
approve Eagle V1.2 Imaging System use in
clinical trial SBI-CIP 20-002
1.2. Terminology Used
Table 2 Terminology Used
Term / Acronym
Definition / Meaning
EtO
EtO Sterilization is a low-temperature process that uses Ethylene Oxide gas to
reduce the level of infectious agents.
Tx
Transmit
Rx
Receive
ALA
aminolevulinic acid
P/N
Part Number
GB
Gigabyte
Type-C
USB-C (formally known as USB Type-C) is a 24-pin USB connector system with a
rotationally symmetrical connector
Cm
centimeter