FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACUSON AL538 TRANSDUCER
K Number: K854788
·
Decision Jan 15, 1986
Classifications
1
FEI Numbers
388
Registration Numbers
389
Same Product Code
407
Applicant Total
24
Review Days
47
Basic Information
- Device Name
- ACUSON AL538 TRANSDUCER
- K Number
- K854788
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- ACUSON COMPUTED SONOGRAPHY
- Date Received
- November 29, 1985
- Decision Date
- January 15, 1986
- Product Code
- ITX
- 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 |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | FDA class 2 | Radiology |
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Other Clearances by ACUSON COMPUTED SONOGRAPHY
| K Number | Device Name | ||
|---|---|---|---|
| K893863 | ACUSON L538 TRANSDUCER | May 23, 1990 | Substantially Equivalent |
| K874028 | ACUSON S328 TRANSDUCER | Jun 21, 1988 | Substantially Equivalent |
| K874861 | ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP. | May 11, 1988 | Substantially Equivalent |
| K874363 | ACUSON S228 AND S328 TRANSDUCERS FOR ABDOM. APPLI. | May 2, 1988 | Substantially Equivalent |
| K874922 | ACUSON TRANSPERINEAL NEEDLE GUIDE | Feb 19, 1988 | Substantially Equivalent |
| K874860 | ACUSON I7505 TRANSDUCER FOR INTRACAVITARY APPLICA. | Feb 17, 1988 | Substantially Equivalent |
| K871506 | ACUSON L538 TRANSDUCER | Sep 28, 1987 | Substantially Equivalent |
| K871416 | AUXILIARY CONTINUOUS WAVE DOPPLER TRANSDUCER | Sep 28, 1987 | Substantially Equivalent |
| K871239 | ACUSON PHYSIOLOGICAL CONTROL MODULE | Jun 5, 1987 | Substantially Equivalent |
| K864578 | ACUSON TV519 TRANSDUCER | Mar 27, 1987 | Substantially Equivalent |