FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

PROCESSOR, VIDEO IMAGE VIP-550

K Number: K780165 · Decision Mar 2, 1978
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
129
Applicant Total
7
Review Days
30

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Basic Information

Device Name
PROCESSOR, VIDEO IMAGE VIP-550
K Number
K780165
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
892.1100
Medical Specialty
Radiology
Decision
Substantially Equivalent
Applicant
Ohio Nuclear, Inc.
Date Received
January 31, 1978
Decision Date
March 2, 1978
Product Code
IYX
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
IYX Camera, Scintillation (Gamma)

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Other 510(k) clearances with the same product code (IYX), ordered by most recent decision date.

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Other Clearances by Ohio Nuclear, Inc.

K Number Device Name
K792603 COMPUTED TOMOGRAPHY X-RAY SCANNER
K791195 DELTASCAN COMPUTER TOMOGRAPHY X-RAY SCAN
K781079 SONOGRAF ULTRASOUND B-SCANNING SYSTEM
K780115 SCANNERS, TOMOGRAPHIC, COMPUTED
K772305 RAD. THERAPY PLANNING SUP. SYS.
K771082 DELTASCAN 2000 SERIES