INFX-8000F (INFINIX CSI AND INFINIX DPI)— 510(k) K081624
Substantially EquivalentToshiba America Medical Systems, In.C
FDA 510(k) clearance K081624 for INFX-8000F (INFINIX CSI AND INFINIX DPI), Substantially Equivalent on 2008-06-23. Applicant: Toshiba America Medical Systems, In.C. Device class: 2.
Clearance details
- Applicant
- Toshiba America Medical Systems, In.C
- Product code
- Code MQB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tustin, CA, US
Recent devices under product code MQB
view allMore clearances from Toshiba America Medical Systems, In.C
view allRecalls naming K081624
K-number listed on FDA's recall record- Z-1176-2021 — System INFX-8000F
- Z-1271-2021 — Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lower extremities.
- Z-2327-2020 — Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
- Z-0360-2020 — Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System (Interventional Angiography System), to position patient during diagnostic and interventional x-ray angiography.
- Z-0842-2018 — INFX-8000F Fluoroscopic X-Ray Systems
- Z-0994-2013 — Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081624.
Data sourced from openFDA. This site is unofficial and independent of the FDA.