FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TBX MEDICAL X-RAY TABLE
K Number: K854459
·
Decision Feb 12, 1986
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
14
Applicant Total
14
Review Days
98
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Basic Information
- Device Name
- TBX MEDICAL X-RAY TABLE
- K Number
- K854459
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1910
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Gendex Corp.
- Date Received
- November 6, 1985
- Decision Date
- February 12, 1986
- Product Code
- IXJ
- 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 |
|---|---|---|---|
| IXJ | Grid, Radiographic | FDA class 1 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IXJ), ordered by most recent decision date.
MITAYA ALUMINUM INTERSPACED X-RAY GRID
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FIBRE INTERSPACED X-RAY GRID
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RADIOGRAPHIC GRID
FDA 510(k)
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HIGH TRANSMISSION CELLULAR (HTC) GRIDS 18X24 CM & 24X30 CM SIZES
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SK S-RAY GRIDS
FDA 510(k)
FDA Class 1
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JPI X-RAY GRID
FDA 510(k)
FDA Class 1
·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 |
| K894188 | GX-ELEVATOR | Oct 3, 1989 | Substantially Equivalent |
| K890083 | GX-2000 STATIONARY X-RAY GENERATOR | Mar 31, 1989 | Substantially Equivalent |