FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION
K Number: K950608
·
Decision Mar 2, 1995
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
175
Applicant Total
12
Review Days
21
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Basic Information
- Device Name
- DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION
- K Number
- K950608
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1710
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lorad Corp.
- Date Received
- February 9, 1995
- Decision Date
- March 2, 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 |
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Other Clearances by Lorad Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K992280 | LORAD 1-650 (INTERNATIONAL 650) | Sep 3, 1999 | Substantially Equivalent |
| K974460 | LITE TOUCH ERBIUM LASER TREATMENT SYSTEM | Jan 16, 1998 | Substantially Equivalent |
| K973631 | LORAD M-III ELITE (M-III E) | Dec 23, 1997 | Substantially Equivalent |
| K952210 | LORAD STEROLOC II | Jul 24, 1995 | Substantially Equivalent |
| K945241 | LORAD M-IV, LORAD M-IVI | Mar 31, 1995 | Substantially Equivalent |
| K945496 | MAMMOGRAPHIC X-RAY UNIT | Dec 27, 1994 | Substantially Equivalent |
| K945272 | RHODIUM FILTER | Dec 14, 1994 | Substantially Equivalent |
| K934868 | LORAD TRANSPO | Oct 14, 1994 | Substantially Equivalent |
| K934870 | LORAD D-550 | Jan 31, 1994 | Substantially Equivalent |
| K934748 | LORAD M-IIE MODIFICATION | Jan 31, 1994 | Substantially Equivalent |