FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LINEAR ARRAY SCANNER
K Number: K800805
·
Decision Jul 21, 1980
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
77
Applicant Total
190
Review Days
102
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
- LINEAR ARRAY SCANNER
- K Number
- K800805
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Philips Medical Systems (Cleveland), Inc.
- Date Received
- April 10, 1980
- Decision Date
- July 21, 1980
- Product Code
- DXK
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DXK | Echocardiograph | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXK), ordered by most recent decision date.
Ultra ICE Plus PI 9 MHz Peripheral Imaging Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
FDA 510(k)
FDA Class 2
·Cardiovascular
IN-VISION IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
9750 ATHENA ETHERNET OPTION
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCESSORY TO GENESIS III (GCFM)
FDA 510(k)
FDA Class 2
·Cardiovascular
CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600
FDA 510(k)
FDA Class 2
·Cardiovascular
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 |