FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DSP OPTION
K Number: K945580
·
Decision Jan 30, 1995
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
11
Applicant Total
190
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
- DSP OPTION
- K Number
- K945580
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1620
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Philips Medical Systems (Cleveland), Inc.
- Date Received
- November 14, 1994
- Decision Date
- January 30, 1995
- Product Code
- IZJ
- 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 |
|---|---|---|---|
| IZJ | Camera, X-Ray, Fluorographic, Cine Or Spot | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IZJ), ordered by most recent decision date.
CCD CAMERA, MODEL PKP-06000-000
FDA 510(k)
FDA Class 2
·Radiology
DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR
FDA 510(k)
FDA Class 2
·Radiology
PHILIPS DSI SYSTEM RELEASE 3.2
FDA 510(k)
FDA Class 2
·Radiology
CINE CAMERA CONTROL MODEL PK2037
FDA 510(k)
FDA Class 2
·Radiology
DTV-4114 FLUOROSCOPIC TELEVISION CAMERA
FDA 510(k)
FDA Class 2
·Radiology
CANON X-RAY 35MM CINE CAMERA CSI-35
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Philips Medical Systems (Cleveland), Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K171850 | Philips CT Big Bore | Nov 9, 2017 | Substantially Equivalent |
| K172406 | Ingenuity TF | Oct 6, 2017 | Substantially Equivalent |
| K162838 | Philips iCT CT System | Apr 7, 2017 | Substantially Equivalent |
| K163711 | IQon Spectral CT | Apr 5, 2017 | Substantially Equivalent |
| K170086 | Pinnacle Radiation Therapy Planning System | Feb 9, 2017 | Substantially Equivalent |
| K160743 | Philips Ingenuity CT | Aug 8, 2016 | Substantially Equivalent |
| K153444 | Philips Multislice CT System with Low Dose CT Lung Cancer | Apr 8, 2016 | Substantially Equivalent |
| K130992 | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM | Jun 14, 2013 | Substantially Equivalent |
| K111336 | EBW NM 2.0 | May 24, 2011 | Substantially Equivalent |
| K111024 | JETPACK 2.0 | Apr 21, 2011 | Substantially Equivalent |