FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DENTAL XERORADIOGRAPHY
K Number: K791014
·
Decision Sep 4, 1979
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
41
Applicant Total
5
Review Days
95
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Basic Information
- Device Name
- DENTAL XERORADIOGRAPHY
- K Number
- K791014
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1810
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Xerox Medical Systems
- Date Received
- June 1, 1979
- Decision Date
- September 4, 1979
- Product Code
- EAP
- 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 |
|---|---|---|---|
| EAP | Unit, X-Ray, Intraoral | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EAP), ordered by most recent decision date.
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MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM
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Other Clearances by Xerox Medical Systems
| K Number | Device Name | ||
|---|---|---|---|
| K853459 | XERORADIOGRAPHY LIQUID TONER IMAGING SYSTEM | Oct 30, 1985 | Substantially Equivalent |
| K833243 | MAMMOGRAPHIC S-RAY SYSTEM | Oct 28, 1983 | Substantially Equivalent |
| K832733 | XEROX 120 SYS MAMMOGRAPHIC X-RAY | Sep 29, 1983 | Substantially Equivalent |
| K812024 | XEROX 128 CASSETTE CHANGER | Aug 13, 1981 | Substantially Equivalent |