FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIASONICS SMALL PARTS SCANNER
K Number: K802979
·
Decision Jan 22, 1981
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
1117
Applicant Total
42
Review Days
62
Basic Information
- Device Name
- DIASONICS SMALL PARTS SCANNER
- K Number
- K802979
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- DIASONICS, INC.
- Date Received
- November 21, 1980
- Decision Date
- January 22, 1981
- Product Code
- IYN
- 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 |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | FDA class 2 | Radiology |
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|---|---|---|---|
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| K903562 | CW DOPPLER 2.25 MHZ PROBE | Mar 2, 1992 | Substantially Equivalent |
| K903984 | CW DOPPLER/4.5 MHZ | Jun 14, 1991 | Substantially Equivalent |
| K896637 | ACCESS(TM), SOFTWARE RELEASE 4.11P | Jan 22, 1990 | Substantially Equivalent |
| K893518 | MT/S SOFTWARE RELEASE 5.0. | Oct 27, 1989 | Substantially Equivalent |
| K894290 | ACCESS TM | Sep 7, 1989 | Substantially Equivalent |
| K893881 | ACCESS TM | Jun 23, 1989 | Substantially Equivalent |