FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GX-770 X-RAY CONTROL, MODEL 46-404600G4
K Number: K935046
·
Decision Feb 18, 1994
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
189
Applicant Total
14
Review Days
121
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Basic Information
- Device Name
- GX-770 X-RAY CONTROL, MODEL 46-404600G4
- K Number
- K935046
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gendex Corp.
- Date Received
- October 20, 1993
- Decision Date
- February 18, 1994
- Product Code
- EHD
- Advisory Committee
- Dental
- 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 |
|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | FDA class 2 | Dental |
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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 |
| 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 |
| K873982 | GX-MOBILE X-RAY UNIT | Oct 30, 1987 | Substantially Equivalent |