FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ATHENA HFX
K Number: K945619
·
Decision Mar 23, 1995
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
175
Applicant Total
69
Review Days
128
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Basic Information
- Device Name
- ATHENA HFX
- K Number
- K945619
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1710
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Fischer Imaging Corp.
- Date Received
- November 15, 1994
- Decision Date
- March 23, 1995
- Product Code
- IZH
- 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 |
|---|---|---|---|
| IZH | System, X-Ray, Mammographic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IZH), ordered by most recent decision date.
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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 |
| K961207 | EP-X BIPLANE | Aug 20, 1996 | Substantially Equivalent |
| K961022 | TANGENT VI TABLE | May 3, 1996 | Substantially Equivalent |
| K950291 | DIGITAL 625HF | 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 |