FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIASONICS DRF-200 ULTRASOUND IMAGING SYSTEM
K Number: K851860
·
Decision Oct 31, 1985
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
42
Review Days
188
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Basic Information
- Device Name
- DIASONICS DRF-200 ULTRASOUND IMAGING SYSTEM
- K Number
- K851860
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Diasonics, Inc.
- Date Received
- April 26, 1985
- Decision Date
- October 31, 1985
- Product Code
- IYO
- 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
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Other Clearances by Diasonics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962662 | VINGMED SOUND COLOR FLOW MAPPING SYSTEM | Jan 2, 1997 | Substantially Equivalent |
| K924079 | CFM-800 COLOR FLOW MAPPING SYSTEM | Sep 28, 1993 | Substantially Equivalent |
| K911435 | CPA/3.5 MHZ PROBE | Sep 11, 1992 | Substantially Equivalent |
| K905200 | SACA, 3.5 MHZ PROBE | Apr 2, 1992 | Substantially Equivalent |
| 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 |