FLUOROspeed— 510(k) K191877
Substantially EquivalentShimadzu Corporation
FDA 510(k) clearance K191877 for FLUOROspeed, Substantially Equivalent on 2019-08-05. 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 K191877
K-number listed on FDA's recall record- Z-0317-2025 — The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. FLUOROspeed may be used for emergency treatment on an outpatient basis, as well as for bedside examinations.
- Z-0867-2022 — MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K191877.
Data sourced from openFDA. This site is unofficial and independent of the FDA.