FDA 510(k) K954255 Summary, PHILIPS TOMOSCAN SR 8000, by Philips Medical Systems North America, Inc.
FDA 510(k) K954255 Summary, PHILIPS TOMOSCAN SR 8000, by Philips Medical Systems North America, Inc.
NOTE: Summary of Safety and Effectiveness Document Only
Device Classification Name: System, X-Ray, Tomography, Computed
510(k) Number: K954255
Device Name: PHILIPS TOMOSCAN SR 8000
Applicant: Philips Medical Systems North America, Inc.
Regulation Number: 892.1750
Classification Product Code: JAK
Date Received: 09/11/1995
Decision Date: 10/07/1995
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
510k Review Panel: Radiology
Total number of pages: 1
Fully redacted pages: 0
Content pages: 1
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