FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INVENTOR RT/EXPLORER TRAUMA UNIT
K Number: K911563
·
Decision Oct 23, 1991
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
39
Applicant Total
27
Review Days
198
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Basic Information
- Device Name
- INVENTOR RT/EXPLORER TRAUMA UNIT
- K Number
- K911563
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1770
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Continental X-Ray Corp.
- Date Received
- April 8, 1991
- Decision Date
- October 23, 1991
- Product Code
- IYB
- 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 |
|---|---|---|---|
| IYB | Tube Mount, X-Ray, Diagnostic | FDA class 1 | 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 |
| K961690 | CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105 | Jun 27, 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 |