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510(k) K970999

SONY PGM-100P1MD TRINITRON COLOR GRAPHIC MONITOR by Sony Medical Systems — Product Code JAK

K970999 is an FDA 510(k) premarket notification submitted by Sony Medical Systems for the device "SONY PGM-100P1MD TRINITRON COLOR GRAPHIC MONITOR". The FDA issued a decision of Substantially Equivalent on May 20, 1997. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Sony Medical Systems has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1997
Date Received
March 19, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

Other clearances by Sony Medical Systems

  • K024188 — UP-DF500 FILMSTATION DIGITAL FILM IMAGER (February 4, 2003)
  • K961680 — SONY DKR-700 DIGITAL STILL RECORDER (July 3, 1996)
  • K931170 — SONY CARDIAC ANALYSIS AND REVIEW STATION (CARS) (June 14, 1993)
  • K924708 — CINENET CARDIAC IMAGE NETWORK (December 30, 1992)
  • K921275 — SONY LASER VIDEODISC RECORDING SYSTEM (June 10, 1992)

Other clearances for product code JAK

  • K253560 — Enhanced Boundary for PCCT (June 24, 2026)
  • K253026 — Respiratory Gating for Scanners (2.1) (June 4, 2026)
  • K253596 — Aquilion ONE (TSX-308A/TSX-306A) V2.0 (May 20, 2026)
  • K253649 — Spectral CT Verida Family (March 27, 2026)
  • K252992 — CT Rembra RT; CT Areta RT; CT Rembra (March 23, 2026)
  • K253686 — True Definition DL (March 23, 2026)
  • K253520 — Photonova Spectra, Photonova Spectra Select (March 20, 2026)
  • K253574 — SOMATOM X.cite; SOMATOM X.ceed (March 20, 2026)
  • K260078 — Aquilion ServeSP (TSX-307B) V2.0 (March 13, 2026)
  • K252249 — Extremity CT Imaging System (March 13, 2026)

FDA data resources