X-RAY TV SYSTEM SONIALVISION G4— 510(k) K142341
Substantially EquivalentShimadzu Corp.
FDA 510(k) clearance K142341 for X-RAY TV SYSTEM SONIALVISION G4, Substantially Equivalent on 2015-03-06. Applicant: Shimadzu Corp.. Device class: 2.
Clearance details
- Applicant
- Shimadzu Corp.
- 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
- Abbreviated
- Location
- Kyoto, JP
Recent devices under product code JAA
view allMore clearances from Shimadzu Corp.
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 K142341
K-number listed on FDA's recall record- Z-0868-2022 — MODEL: X-RAY TV SYSTEM SONIALVISION G4
- Z-0917-2017 — Shimadzu X-ray TV System, Catalog No. SONIALVISION G4
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142341.
Data sourced from openFDA. This site is unofficial and independent of the FDA.