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
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
37
Review Days
10
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
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LLZ), ordered by most recent decision date.
2D Hip Planning Software
FDA 510(k)
FDA Class 2
·Radiology
CustoMED Viewer
FDA 510(k)
FDA Class 2
·Radiology
Helion Viewer Suite
FDA 510(k)
FDA Class 2
·Radiology
CMN Capillary Function with Virtual Expert for MRI, CT and CBCT
FDA 510(k)
FDA Class 2
·Radiology
SubtleHD-PET (1.x)
FDA 510(k)
FDA Class 2
·Radiology
HipGuide (V 1.0.0.0)
FDA 510(k)
FDA Class 2
·Radiology
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 |