FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

INTERSON MULTIPLANE RECTAL PROBE FOR ALOKA ULTRA.

K Number: K900555 · Decision May 2, 1990
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
9
Review Days
85

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Basic Information

Device Name
INTERSON MULTIPLANE RECTAL PROBE FOR ALOKA ULTRA.
K Number
K900555
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
892.1570
Medical Specialty
Radiology
Decision
Substantially Equivalent
Applicant
Interson Corp.
Date Received
February 6, 1990
Decision Date
May 2, 1990
Product Code
ITX
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
ITX Transducer, Ultrasonic, Diagnostic

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Other Clearances by Interson Corp.

K Number Device Name
K911116 INTERSON ENDOCAVITY PROBE/KONTRON ULTRASOUND SYST
K911113 INTERSON TRANSRECTAL PROBE/KONTRON ULTRASOUND SYST
K911117 INTERSON ENDOCAVITY PROBE FOR ATL ULTRASOUND SYST
K911115 INTERSON TRANSRECTAL PROBE/ATL ULTRASOUND SYSTEM
K911114 INTERSON ENDOCAVITY PROBE/ALOKA ULTRASOUND SYSTEM
K911464 INTERSON DISPOSABLE BIOPSY NEEDLE
K896680 PROBE SHEATH FOR ADMS & CAPISTRANO LABS TRANSREC.
K895725 BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES