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

PREFERNCE IMRT TREATMENT PLANNING MODULE

K Number: K012575 · Decision Mar 12, 2002
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
255
Applicant Total
6
Review Days
215

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Basic Information

Device Name
PREFERNCE IMRT TREATMENT PLANNING MODULE
K Number
K012575
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
892.5050
Medical Specialty
Radiology
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Northwest Medical Physics Equipment, Inc.
Date Received
August 9, 2001
Decision Date
March 12, 2002
Product Code
MUJ
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
MUJ System, Planning, Radiation Therapy Treatment

Similar 510(k) Clearances

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

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Other Clearances by Northwest Medical Physics Equipment, Inc.

K Number Device Name
K063274 ACCULOC BREAST LOCALIZATION SYSTEM
K001833 PREFERENCE TREATMENT SYSTEM
K983793 PREFERENCE TREATMENT SYSTEM
K970464 P REFERENCE TPS (TREATMENT PLANNING SOFTWARE) 1.1
K960293 MRTOFLM COMPUTER PROGRAM