FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GX-ELEVATOR
K Number: K894188
·
Decision Oct 3, 1989
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
28
Applicant Total
14
Review Days
109
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
- GX-ELEVATOR
- K Number
- K894188
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1980
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Gendex Corp.
- Date Received
- June 16, 1989
- Decision Date
- October 3, 1989
- Product Code
- IZZ
- 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 |
|---|---|---|---|
| IZZ | Table, Radiographic, Non-Tilting, Powered | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IZZ), ordered by most recent decision date.
MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE
FDA 510(k)
FDA Class 2
·Radiology
MED-TRON SPECT IMAGING TABLE
FDA 510(k)
FDA Class 2
·Radiology
CATHETERIZATION TABLE KS-60
FDA 510(k)
FDA Class 2
·Radiology
ANGIOREX CAT-350B
FDA 510(k)
FDA Class 2
·Radiology
RAPIDO 2000 AUTOMATIC RADIOGRAPHIC TABLE
FDA 510(k)
FDA Class 2
·Radiology
ALPHA
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Gendex Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K952598 | GX-PAN PANORAMIC DENTAL X-RAY SYSTEM | Jun 29, 1995 | Substantially Equivalent |
| K945682 | PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL | Feb 9, 1995 | Substantially Equivalent |
| K935046 | GX-770 X-RAY CONTROL, MODEL 46-404600G4 | Feb 18, 1994 | Substantially Equivalent |
| K925094 | VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS | Sep 29, 1993 | Substantially Equivalent |
| K931001 | ORALIX DC | Sep 14, 1993 | Substantially Equivalent |
| K932675 | GXP DENTAL X-RAY PROCESSOR | Jul 26, 1993 | Substantially Equivalent |
| K922165 | ATC725, ATC525, AND AP300 | Jul 27, 1992 | Substantially Equivalent |
| K920189 | GX-C CEPHALOMETER | Apr 28, 1992 | Substantially Equivalent |
| K890083 | GX-2000 STATIONARY X-RAY GENERATOR | Mar 31, 1989 | Substantially Equivalent |
| K873982 | GX-MOBILE X-RAY UNIT | Oct 30, 1987 | Substantially Equivalent |