BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER— 510(k) K042293
Substantially EquivalentPhilips Medical Systems (Cleveland), Inc.
FDA 510(k) clearance K042293 for BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER, Substantially Equivalent on 2004-09-08. 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 K042293
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042293.
Data sourced from openFDA. This site is unofficial and independent of the FDA.