Regulatory

Regulatory


USA

Product Name Trade Names FDA 510(k)
SpeqT Uscan K160420
SpeqRT Ultrasound System SignosRT Personal Ultrasound K130659
SignosRT
SONIMAGE P3
SignosRT Bladder Ultrasound System SignosRT Bladder K143493
Speq Ultrasound System Signos K090505
Signos Personal Ultrasound

Australia

Product Name Trade Names Registration Number
Speq Ultrasound System Uscan AU Q00219
Signos
SignosRT Personal Ultrasound
SignosRT
SignosRT Bladder

Europe

Product Name Trade Names Registration Number
Speq Ultrasound System Uscan MRA Q00063
Signos
SignosRT Personal Ultrasound
SignosRT
SignosRT Bladder

Japan

Product Name License Number
Uscan 228APBZI00001000

Canada

Product Name Trade Names License Number
SpeqRT Ultrasound System SpeqRT 93446
SignosRT
SONIMAGE P3 93445

Singapore

Product Name Trade Names Registration Number
SpeqRT Ultrasound System SpeqRT DE0016377
SignosRT
SONIMAGE P3

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