Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5— 510(k) K212960
Substantially EquivalentCanon Medical Systems Corporation
FDA 510(k) clearance K212960 for Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5, Substantially Equivalent on 2022-03-22. Applicant: Canon Medical Systems Corporation. Device class: 2.
Clearance details
- Applicant
- Canon Medical Systems Corporation
- 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
- Otawara-Shi, JP
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- K253597 — Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System
Adverse 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 K212960
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K212960.
Data sourced from openFDA. This site is unofficial and independent of the FDA.