Philips Ingenuity CT— 510(k) K160743
Substantially EquivalentPhilips Medical Systems (Cleveland), Inc.
FDA 510(k) clearance K160743 for Philips Ingenuity CT, Substantially Equivalent on 2016-08-08. Applicant: Philips Medical Systems (Cleveland), Inc.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems (Cleveland), Inc.
- Product code
- Code JAK
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cleveland, OH, US
Recent devices under product code JAK
view allMore clearances from Philips Medical Systems (Cleveland), Inc.
view allAdverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
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 K160743
K-number listed on FDA's recall record- Z-3042-2026 — Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x
- Z-2652-2026 — Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 128 Elite Brazil
- Z-2600-2025 — Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326, Model Number: 728323. 3. Ingenuity CT, Model Number: 728326.
- Z-2315-2021 — Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system
- Z-2316-2021 — 728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
- Z-1984-2021 — Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT
- Z-2186-2019 — Ingenuity CT, Model # 728326, computed tomography x-ray system
- Z-2187-2019 — Ingenuity Core128 Model # 728323, computed tomography x-ray system
- Z-2188-2019 — Ingenuity Core Model # 728321, computed tomography x-ray system
- Z-2274-2018 — Philips Ingenuity Core 728321
- Z-2275-2018 — Ingenuity Core128 728323
- Z-2277-2018 — Ingenuity Core128/Elite China 728324
- Z-0390-2018 — Ingenuity Core, (Code 728321) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
- Z-0391-2018 — Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
- Z-0518-2018 — Philips Brilliance 64 computed tomography x-ray system
- Z-0519-2018 — Philips Ingenuity Core computed tomography x-ray system
- Z-0520-2018 — Philips Ingenuity Core 128 computed tomography x-ray system
- Z-0521-2018 — Philips Ingenuity CT computed tomography x-ray system
- Z-0695-2017 — Ingenuity Core 728321 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories
- Z-0696-2017 — Ingenuity Core 128 728323
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160743.
Data sourced from openFDA. This site is unofficial and independent of the FDA.