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
EAP Unit, X-Ray, Intraoral

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Other Clearances by Xerox Medical Systems

K Number Device Name
K853459 XERORADIOGRAPHY LIQUID TONER IMAGING SYSTEM
K833243 MAMMOGRAPHIC S-RAY SYSTEM
K832733 XEROX 120 SYS MAMMOGRAPHIC X-RAY
K812024 XEROX 128 CASSETTE CHANGER