FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
K Number: K023772
·
Decision Nov 22, 2002
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
37
Review Days
10
Basic Information
- Device Name
- KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
- K Number
- K023772
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ACUSON CORP.
- Date Received
- November 12, 2002
- Decision Date
- November 22, 2002
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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Other Clearances by ACUSON CORP.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K992580 | FETAL ASSESSMENT CAP | Oct 18, 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 |