FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AU6
K Number: K990360
·
Decision Apr 30, 1999
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
1117
Applicant Total
20
Review Days
84
Basic Information
- Device Name
- AU6
- K Number
- K990360
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BIOSOUND ESAOTE, INC.
- Date Received
- February 5, 1999
- Decision Date
- April 30, 1999
- 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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Other Clearances by BIOSOUND ESAOTE, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K023255 | TECHNOS MP, MODEL AU6 | Feb 11, 2003 | Substantially Equivalent |
| K014168 | AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION) | Apr 25, 2002 | Substantially Equivalent |
| K020164 | E-SCAN XQ | Feb 12, 2002 | Substantially Equivalent |
| K012728 | E-SCAN MRI SYSTEM | Aug 29, 2001 | Substantially Equivalent |
| K010405 | 7230 ULTRASOUND IMAGING SYSTEM WITH TEI | Mar 13, 2001 | Substantially Equivalent |
| K010057 | MODIFICATION TO ARTOSCAN M | Feb 2, 2001 | Substantially Equivalent |
| K001894 | MODIFICATION TO E-SCAN | Jul 6, 2000 | Substantially Equivalent |
| K000931 | AU5 ULTRASOUND IMAGING SYSTEM | Jun 8, 2000 | Substantially Equivalent |
| K000681 | AU5, AU6 | May 3, 2000 | Substantially Equivalent |
| K994369 | 7250 (MEGAS) | Feb 24, 2000 | Substantially Equivalent |