Model: Signature 20 BT27
DI: 00198953121382
Status: New
MRI: MR Safe
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-28
Current Version: 2026-06-05
Description
Voluson Signature 20 BT27
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
be685a91-42a6-405b-adeb-1e1c62517975
Distribution Status:
In Commercial Distribution
DUNS Number:
690168810
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00198953121382
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 40761
Name: General-purpose ultrasound imaging system
Definition:
A stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.
FDA Product Codes
ITX
Transducer, Ultrasonic, Diagnostic
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
IYO
System, Imaging, Pulsed Echo, Ultrasonic
Premarket Submissions
Submission Number:
K233692
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
18
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
30
Item #1 - Storage Handling Type:
Handling Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling Low - @attributes - Value:
30
Item #2 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Value:
75
Item #2 - Storage Handling Type:
Handling Environment Humidity
Item #3 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #3 - Storage Handling Low - @attributes - Value:
70
Item #3 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #3 - Storage Handling High - @attributes - Value:
106
Item #3 - Storage Handling Type:
Handling Environment Atmospheric Pressure
Item #4 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #4 - Storage Handling Low - @attributes - Value:
-10
Item #4 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #4 - Storage Handling High - @attributes - Value:
50
Item #4 - Storage Handling Type:
Storage Environment Atmospheric Pressure
Item #5 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #5 - Storage Handling Low - @attributes - Value:
10
Item #5 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #5 - Storage Handling High - @attributes - Value:
85
Item #5 - Storage Handling Type:
Storage Environment Humidity
Item #6 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #6 - Storage Handling Low - @attributes - Value:
70
Item #6 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #6 - Storage Handling High - @attributes - Value:
106
Item #6 - Storage Handling Type:
Storage Environment Atmospheric Pressure