SonialVision G4— 510(k) K190373
Substantially EquivalentShimadzu Corporation
FDA 510(k) clearance K190373 for SonialVision G4, Substantially Equivalent on 2019-03-15. Applicant: Shimadzu Corporation. Device class: 2.
Clearance details
- Applicant
- Shimadzu Corporation
- Product code
- Code JAA
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Kyoto, JP
Recent devices under product code JAA
view allMore clearances from Shimadzu Corporation
view allAdverse events under product code JAA
product code JAA- Other
- 1
- Total
- 1
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 K190373
K-number listed on FDA's recall record- Z-0316-2025 — SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammography.
- Z-0869-2022 — MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190373.
Data sourced from openFDA. This site is unofficial and independent of the FDA.