FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EP-X BIPLANE
K Number: K961207
·
Decision Aug 20, 1996
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
299
Applicant Total
69
Review Days
146
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Basic Information
- Device Name
- EP-X BIPLANE
- K Number
- K961207
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Fischer Imaging Corp.
- Date Received
- March 27, 1996
- Decision Date
- August 20, 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 Fischer Imaging Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K042095 | MAMMOTEST | Oct 29, 2004 | Substantially Equivalent |
| K021113 | MAMMOPATH | Jun 13, 2002 | Substantially Equivalent |
| K981414 | LC POSITIONER | Jul 16, 1998 | Substantially Equivalent |
| K973400 | MAMMOTEST ADAPTER DRIVER | Nov 10, 1997 | Substantially Equivalent |
| K964806 | MD-1835 | Mar 4, 1997 | Substantially Equivalent |
| K961022 | TANGENT VI TABLE | May 3, 1996 | Substantially Equivalent |
| K950291 | DIGITAL 625HF | Mar 23, 1995 | Substantially Equivalent |
| K945619 | ATHENA HFX | Mar 23, 1995 | Substantially Equivalent |
| K944147 | MICRO X-50 HF | Sep 16, 1994 | Substantially Equivalent |
| K944149 | MICRO X-80 HF | Sep 16, 1994 | Substantially Equivalent |