Device type
System, Imaging, Pulsed Echo, Ultrasonic
Product code IYO · Class II · 21 CFR 892.1560 · Radiology
Recent 510(k)s
Oct 28, 2026
K261648
Evident Vascular™ Guidance System
Evident Vascular, Inc.
- IYO
- Class II
Oct 20, 2026
K262093
Accuro XV
Rivanna Medical, Inc.
- IYO
- Class II
Oct 16, 2026
K260605
Lilium one (USM330)
Lilium Otsuka Co., Ltd.
- IYO
- Class II
Sep 24, 2026
K260313
MD-6000S Bladder Scanner
MEDA Co., Ltd.
- IYO
- Class II
Recent recalls
Oct 7, 2026
Z-3276-2026
Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Volcano Corp
- IYO
- Class II
- Ongoing