Scatter Correction Volume Software Model NSSC-020A

FDA 510(k) K960948 · Toshiba Medical Systems

Substantially Equivalent

510(k) numberK960948

Submission

Device name
Scatter Correction Volume Software Model NSSC-020A
Applicant
Toshiba Medical Systems
Tustin, CA, US
Received
March 8, 1996
Decision date
December 23, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KPS – System, Tomography, Computed, Emission
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1200
Specialty
Radiology

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Questions and answers

When was Scatter Correction Volume Software Model NSSC-020A cleared by the FDA?

Scatter Correction Volume Software Model NSSC-020A (K960948) received a 510(k) decision of Substantially Equivalent on December 23, 1996, 290 days after the submission was received.

What is the product code of K960948?

The FDA product code is KPS – System, Tomography, Computed, Emission, a Class II (moderate risk) device regulated under 21 CFR 892.1200.