Ultrasound System SONIMAGE HS1— 510(k) K162065
Substantially EquivalentKonica Minolta, Inc.
FDA 510(k) clearance K162065 for Ultrasound System SONIMAGE HS1, Substantially Equivalent on 2016-10-19. Applicant: Konica Minolta, Inc.. Device class: 2.
Clearance details
- Applicant
- Konica Minolta, Inc.
- Product code
- Product code IYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hino-Shi, JP
Recent devices under product code IYN
view all- K261585 — Diagnostic Ultrasound System (Nuewa A20W) +10 more
- K261617 — Diagnostic Ultrasound System (11+ models)
- K263150 — V10 Diagnostic Ultrasound System +10 more
- K261933 — Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
- K262548 — EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
More clearances from Konica Minolta, Inc.
view allAdverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K162065
K-number listed on FDA's recall record- Z-1214-2018 — Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463; 2. AAEU, UDI: 04560141946385; 3. A9RR, UDI: 04560141945470
- Z-2769-2017 — Diagnostics Ultrasound System Ultrasounds System Sonimage HS1
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162065.
Data sourced from openFDA. This site is unofficial and independent of the FDA.