FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BENNETT BCA-6 &BCA-9 MOBILE C-ARM UNIT/RADIO/FLOUR
K Number: K883092
·
Decision Oct 13, 1988
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
235
Applicant Total
23
Review Days
83
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Basic Information
- Device Name
- BENNETT BCA-6 &BCA-9 MOBILE C-ARM UNIT/RADIO/FLOUR
- K Number
- K883092
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1720
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Bennett X-Ray Corp.
- Date Received
- July 22, 1988
- Decision Date
- October 13, 1988
- Product Code
- IZL
- 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 |
|---|---|---|---|
| IZL | System, X-Ray, Mobile | FDA class 2 | Radiology |
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Other Clearances by Bennett X-Ray Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K964576 | PROFILE MAMMOGRAPHY SYSTEM (M-PRO) | Jan 10, 1997 | Substantially Equivalent |
| K952672 | VERTICAL INTEGRATED PERFECT VIEW (VIP) RADIOGRAPHIC SYSTEM | Jul 13, 1995 | Substantially Equivalent |
| K944978 | BENNETT X-RAY DIGITAL SPOT IMAGING SYSTEM MODEL M-DSI | May 3, 1995 | Substantially Equivalent |
| K945962 | BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHY | Apr 3, 1995 | Substantially Equivalent |
| K945731 | HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORS | Feb 15, 1995 | Substantially Equivalent |
| K945749 | BENNETT X-RAY TOMOGRAPHY SYSTEM | Feb 15, 1995 | Substantially Equivalent |
| K940701 | BENNETT MAMMOGRAPHY POSITIONING CHAIR MODEL NO. M-PCH | Apr 28, 1994 | Substantially Equivalent |
| K935649 | WHIS-RAD TUBSTAND STRUCTURE/MOBILE PATIENT TROLLEY | Feb 9, 1994 | Substantially Equivalent |
| K935068 | RADIOGRAPHIC GENERATOR HFQ-WHIS | Dec 13, 1993 | Substantially Equivalent |
| K925725 | CONTOUR MAMMOGRAPHY SYSTEM, MODEL NUMBER M-CTR | Feb 26, 1993 | Substantially Equivalent |