Transmission Attenuation Correction (TAC) Package

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K952190 ↗

FDA Product Code

KPS

Device Class

Class II

Regulation

21 CFR Part 892.1200

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Vector Series

  Class II

  FDA 510(k) K921008 Active Cleared 27 Apr 1992

• Dst-Xl

  Class II

  FDA 510(k) K942837 Active Cleared 5 Jan 1995

• Sophycamera Dsx Bodytrak Open recall

  Class I

  FDA 510(k) K911346 Active Cleared 18 Apr 1991

• Sophy Nxt

  Class II

  FDA 510(k) K913641 Active Cleared 17 Dec 1991

• Sophy Series of Nuclear Medicine Computer Systems

  Class I

  FDA 510(k) K872132 Active Cleared 26 Oct 1987

• Ds-7 Nuclear Medicine Gamma Camera

  Class I

  FDA 510(k) K872297 Active Cleared 12 Aug 1987

See all devices from Sopha Medical Systems, Inc. →

• What is the Transmission Attenuation Correction (TAC) Package used for?

  The Transmission Attenuation Correction (TAC) Package is designed to correct for transmission attenuation in imaging processes, supporting accurate image reconstruction in nuclear medicine and radiology applications by improving the quality of computed tomography emission tomography scans.

• How is the Transmission Attenuation Correction (TAC) Package supplied and by whom?

  The Transmission Attenuation Correction (TAC) Package is supplied by Sopha Medical Systems, Inc., located at 14900 Sweitzer Ln., Suite 200, Laurel, Maryland 20707, United States, as a complete system for use in clinical imaging environments.

• What regulatory pathway was used for the Transmission Attenuation Correction (TAC) Package and when was it cleared?

  The Transmission Attenuation Correction (TAC) Package received FDA 510(k) clearance under K952190 on January 18, 1996, following a traditional submission process, and was found substantially equivalent to a legally marketed predicate device.