Cleared Traditional

PHILIPS TOMOSCAN AV-NT

K991278 · Philips Medical Systems North America, Inc. · Radiology
May 1999
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K991278 is an FDA 510(k) clearance for the PHILIPS TOMOSCAN AV-NT, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Philips Medical Systems North America, Inc. (Shelton, US). The FDA issued a Cleared decision on May 13, 1999, 29 days after receiving the submission on April 14, 1999. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K991278 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 1999
Decision Date May 13, 1999
Days to Decision 29 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAK — System, X-ray, Tomography, Computed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750

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