Company ยท JP
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
FDA 510(k) clearances and medical device recalls filed under this name, 2022 to 2024. Name variants (Inc, Corp, punctuation) are merged.
2510(k) clearances (0 in 12 months)
7recalls (2 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2026 | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Trinias Opera Smart (C16s, F12s)/Opera Grand(C12s,C16s, F12s)/Smart OBL Interventional Fluoroscopic X-Ray System containing C-arm support (MH-500, MH-60), Open, Classified |
OWB | K203535 K221922 |
| Nov 13, 2025 | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M
used with RADspeed, SonialVision and FLUOROspeed Systems
The ceiling type x-ray tube support CH-200 is used to hold the X-ray tube and
collim Open, Classified |
IYB | None listed |
| Nov 7, 2024 | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION 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 gener Open, Classified |
JAA | K191877 |
| Nov 7, 2024 | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION 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 mammo Open, Classified |
JAA | K190373 |
| Oct 22, 2024 | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization table, image processing equipment, x-ray Open, Classified |
OWB | K123508 |
| Mar 14, 2024 | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Shimadzu, Trinias, Digital Angiography System Open, Classified |
OWB | K123508 |
| Jul 31, 2023 | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 units, FluoroSpeed 300 and X1 units Open, Classified |
IYB | None listed |