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

550 TXT TREATMENT TABLE

K Number: K050422 · Decision Mar 18, 2005
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
31
Applicant Total
519
Review Days
28

Basic Information

Device Name
550 TXT TREATMENT TABLE
K Number
K050422
Device Class
FDA class 2
Clearance Type
Special
Regulation Number
892.5770
Medical Specialty
Radiology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
Date Received
February 18, 2005
Decision Date
March 18, 2005
Product Code
JAI
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
JAI Couch, Radiation Therapy, Powered

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