BRILLIANCE VOLUME— 510(k) K060937
Substantially EquivalentPhilips Medical Systems (Cleveland), Inc.
FDA 510(k) clearance K060937 for BRILLIANCE VOLUME, Substantially Equivalent on 2006-06-05. 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 K060937
K-number listed on FDA's recall record- Z-2599-2025 — Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.
- Z-1990-2021 — Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - Brilliance iCT SP
- Z-1774-2021 — BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
- Z-1921-2020 — Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848
- Z-1922-2020 — Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311
- Z-1408-2018 — Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: 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 analysts and display equipment, patient and equipment supports, components, and accessories.
- Z-1409-2018 — Brilliance iCT SP - Model no. 728311 Computed Tomography X-Ray system Product Usage: 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 analysts and display equipment, patient and equipment supports, components, and accessories.
- Z-0331-2018 — Philips Healthcare Brilliance iCT computed tomography x-ray system
- Z-0332-2018 — Philips Healthcare Brilliance iCT SP computed tomography x-ray system
- Z-0402-2018 — Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems
- Z-0403-2018 — Brilliance iCT - Model 728306 Computed Tomography X-ray systems
- Z-1058-2017 — Brilliance iCT
- Z-1004-2017 — Brilliance iCT Product Usage: 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 analysts and display equipment, patient and equipment supports, components, and accessories
- Z-0593-2017 — Brilliance iCT Computed Tomography X-ray system, Model 728306
- Z-0594-2017 — Brilliance ICT SP Computed Tomography X-ray system, Model 728311
- Z-2112-2016 — Brilliance iCT model #728306; Intended to produce cross- sectional images of the body.
- Z-2381-2016 — Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.
- Z-2382-2016 — Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body.
- Z-1506-2016 — IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.
- Z-1352-2016 — Brilliance iCT 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
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060937.
Data sourced from openFDA. This site is unofficial and independent of the FDA.