FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105
K Number: K961690
·
Decision Jun 27, 1996
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
299
Applicant Total
27
Review Days
57
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Basic Information
- Device Name
- CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105
- K Number
- K961690
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Continental X-Ray Corp.
- Date Received
- May 1, 1996
- Decision Date
- June 27, 1996
- Product Code
- JAA
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | FDA class 2 | Radiology |
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Other Clearances by Continental X-Ray Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K972442 | CEILING MOUNTED LATERAL POSITIONER, MODEL NO. 6896.002 | Sep 11, 1997 | Substantially Equivalent |
| K962140 | ICT-2000, INTEGRATED C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM MODEL NO. 6896.300 | Jul 25, 1996 | Substantially Equivalent |
| K954581 | ARC SERIES | Dec 21, 1995 | Substantially Equivalent |
| K950571 | LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270 | Mar 31, 1995 | Substantially Equivalent |
| K942175 | LINEAR TOMOGRAPHIC SYSTEM: PMT 6000 | Aug 17, 1994 | Substantially Equivalent |
| K942100 | MODEL TM EP HIGH VOLTAGE GENERATOR | Jun 7, 1994 | Substantially Equivalent |
| K934686 | MOLYBDENUM/RHODIUM FILTERS | May 26, 1994 | Substantially Equivalent |
| K931724 | ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES | Jun 14, 1993 | Substantially Equivalent |
| K925934 | WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT | Mar 4, 1993 | Substantially Equivalent |
| K921986 | PATIENT INFORMATION MANAGER (PIM) | Oct 16, 1992 | Substantially Equivalent |