FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RADKOR, CST-18
K Number: K882563
·
Decision Jul 8, 1988
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
39
Applicant Total
10
Review Days
17
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, CST-18
- K Number
- K882563
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1770
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Radkor, Inc.
- Date Received
- June 21, 1988
- Decision Date
- July 8, 1988
- Product Code
- IYB
- 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 |
|---|---|---|---|
| IYB | Tube Mount, X-Ray, Diagnostic | FDA class 1 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IYB), ordered by most recent decision date.
SUPERSTAND 300
FDA 510(k)
FDA Class 1
·Radiology
MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000
FDA 510(k)
FDA Class 1
·Radiology
F/C/W TUBESTAND
FDA 510(k)
FDA Class 1
·Radiology
CTS SYSTEM
FDA 510(k)
FDA Class 1
·Radiology
MPR-814
FDA 510(k)
FDA Class 1
·Radiology
MODEL ALPHA TS-2
FDA 510(k)
FDA Class 1
·Radiology
Other Clearances by Radkor, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K895969 | RADKOR DXG-650R | Nov 13, 1989 | Substantially Equivalent |
| 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 |