CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105— 510(k) K961690
Substantially EquivalentContinental X-Ray Corp.
FDA 510(k) clearance K961690 for CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105, Substantially Equivalent on 1996-06-27. Applicant: Continental X-Ray Corp.. Device class: 2.
Clearance details
- Applicant
- Continental X-Ray Corp.
- Product code
- Code JAA
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Broadview, IL, US
Recent devices under product code JAA
view allMore clearances from Continental X-Ray Corp.
view all- K972442 — CEILING MOUNTED LATERAL POSITIONER, MODEL NO. 6896.002
- K962140 — ICT-2000, INTEGRATED C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM MODEL NO. 6896.300
- K954581 — ARC SERIES
- K950571 — LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270
- K942175 — LINEAR TOMOGRAPHIC SYSTEM: PMT 6000
Adverse events under product code JAA
product code JAA- Other
- 1
- Total
- 1
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.