FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RADKOR DXG-650R
K Number: K895969
·
Decision Nov 13, 1989
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
162
Applicant Total
10
Review Days
32
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
- RADKOR DXG-650R
- K Number
- K895969
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1700
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Radkor, Inc.
- Date Received
- October 12, 1989
- Decision Date
- November 13, 1989
- Product Code
- IZO
- 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 |
|---|---|---|---|
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | FDA class 1 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IZO), ordered by most recent decision date.
MPH50, MPH65, AND MPH80
FDA 510(k)
FDA Class 1
·Radiology
HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR
FDA 510(k)
FDA Class 1
·Radiology
N 800 HF
FDA 510(k)
FDA Class 1
·Radiology
SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G
FDA 510(k)
FDA Class 1
·Radiology
MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR
FDA 510(k)
FDA Class 1
·Radiology
POLYDOROS SX 65 AND 80
FDA 510(k)
FDA Class 1
·Radiology
Other Clearances by Radkor, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K892196 | RADKOR TS10-B | Apr 26, 1989 | Substantially Equivalent |
| K891395 | RADKOR BS-10 AND BS-10T | Apr 3, 1989 | Substantially Equivalent |
| K883885 | RADKOR, RF-159 | Oct 19, 1988 | Substantially Equivalent |
| K883864 | RADKOR SFR-70 | Oct 19, 1988 | Substantially Equivalent |
| K881701 | RADKOR SFC-21 | Sep 8, 1988 | Substantially Equivalent |
| K883081 | RADKOR, XG-515 | Sep 2, 1988 | Substantially Equivalent |
| K881696 | RADKOR XG-325 | Sep 2, 1988 | Substantially Equivalent |
| K881700 | RADKOR KOB-84 | Sep 2, 1988 | Substantially Equivalent |
| K882563 | RADKOR, CST-18 | Jul 8, 1988 | Substantially Equivalent |