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

RTS TECHNOLOGY MODELS 721,722,723,724

K Number: K914578 · Decision Feb 28, 1992
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
206
Applicant Total
3
Review Days
133

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Basic Information

Device Name
RTS TECHNOLOGY MODELS 721,722,723,724
K Number
K914578
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
892.5700
Medical Specialty
Radiology
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Rts Technology, Inc.
Date Received
October 18, 1991
Decision Date
February 28, 1992
Product Code
JAQ
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
JAQ System, Applicator, Radionuclide, Remote-Controlled

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Other Clearances by Rts Technology, Inc.

K Number Device Name
K912555 GAMMAMED 12IT HIGH DOSE RATE REMOTE AFTERLOADER
K901589 RTS TECHNOLOGY IRIDIUM 192 SOURCES