FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FETAL ASSESSMENT CAP
K Number: K992580
·
Decision Oct 18, 1999
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
37
Review Days
77
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
- FETAL ASSESSMENT CAP
- K Number
- K992580
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acuson Corp.
- Date Received
- August 2, 1999
- Decision Date
- October 18, 1999
- 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 Acuson Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K023772 | KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM | Nov 22, 2002 | Substantially Equivalent |
| K022896 | CSV12 SOFTWARE VIEWER | Oct 3, 2002 | Substantially Equivalent |
| K022567 | SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM | Aug 13, 2002 | Substantially Equivalent |
| K021497 | CYPRESS ULTRASOUND SYSTEM | Jul 9, 2002 | Substantially Equivalent |
| K010950 | CYPRESS SYSTEM | Jun 27, 2001 | Substantially Equivalent |
| K002807 | 3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING | Dec 1, 2000 | Substantially Equivalent |
| K992631 | ACUNAV DIAGNOSTIC ULTRASOUND CATHETER | Dec 15, 1999 | Substantially Equivalent |
| K991805 | ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION | Aug 2, 1999 | Substantially Equivalent |
| K973767 | HARMONIC IMAGING WITH CONTRAST | Dec 23, 1997 | Substantially Equivalent |
| K973079 | L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM | Nov 5, 1997 | Substantially Equivalent |