FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
ECHO. AKHO
K Number: K951976
·
Decision Jul 26, 1996
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
11
Review Days
456
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ECHO. AKHO
- K Number
- K951976
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Alliance Medical, Inc.
- Date Received
- April 27, 1995
- Decision Date
- July 26, 1996
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IYO), ordered by most recent decision date.
ARTHUR
FDA 510(k)
FDA Class 2
·Radiology
EdgeFlow UW20
FDA 510(k)
FDA Class 2
·Radiology
Accuro XV
FDA 510(k)
FDA Class 2
·Radiology
QT Scanner 2000 Model A
FDA 510(k)
FDA Class 2
·Radiology
IntraSight Plus
FDA 510(k)
FDA Class 2
·Radiology
Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Alliance Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K051438 | VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM) | Apr 4, 2006 | Substantially Equivalent |
| K050518 | REPROCESSED PHACOEMUISIFICATION TIPS | Sep 23, 2005 | Substantially Equivalent |
| K030187 | REPROCESSED ELECTROPHYSIOLOGY CATHETER | Sep 24, 2003 | Substantially Equivalent |
| K021654 | REPROCESSED COMPRESSION SLEEVE | Feb 5, 2003 | Substantially Equivalent |
| K012634 | REPROCESSED EXTERNAL FIXATION DEVICE | Jun 24, 2002 | Substantially Equivalent |
| K012630 | REPROCESSED LINVATEC ARTHROSCOPIC BURS | Nov 9, 2001 | Substantially Equivalent |
| K012611 | REPROCESSED DYONICS ARTHROSCOPIC SHAVERS | Nov 7, 2001 | Substantially Equivalent |
| K012613 | REPROCSSED LINVATEC SHAVERS | Nov 7, 2001 | Substantially Equivalent |
| K990198 | AMIB7 | Jun 29, 1999 | Substantially Equivalent |
| K931091 | DISPOSABLE AMA STERILE DRAPE SHEET, CAT. NO. 5252 | Feb 3, 1994 | Substantially Equivalent |