SONY PGM-100P1MD TRINITRON COLOR GRAPHIC MONITOR— 510(k) K970999

Name: FDA 510(k) clearance K970999
Creator: U.S. Food and Drug Administration
Published: 1997-05-20

Substantially Equivalent

Sony Medical Systems

FDA 510(k) clearance K970999 for SONY PGM-100P1MD TRINITRON COLOR GRAPHIC MONITOR, Substantially Equivalent on 1997-05-20. Applicant: Sony Medical Systems. Device class: 2.

Clearance details

Applicant: Sony Medical Systems
Product code: Code JAK
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 1997-03-19
Decision date: 1997-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JAK

view all

K253836 — FCT iStream Phase 22026-09-04
K253450 — BodyTom Elite (NL4000)2026-07-28
K253770 — CardIQ Suite2026-07-21
K253560 — Enhanced Boundary for PCCT2026-06-24
K253026 — Respiratory Gating for Scanners (2.1)2026-06-04

More clearances from Sony Medical Systems

view all

K024188 — UP-DF500 FILMSTATION DIGITAL FILM IMAGER2003-02-04
K961680 — SONY DKR-700 DIGITAL STILL RECORDER1996-07-03
K931170 — SONY CARDIAC ANALYSIS AND REVIEW STATION (CARS)1993-06-14
K924708 — CINENET CARDIAC IMAGE NETWORK1992-12-30
K921275 — SONY LASER VIDEODISC RECORDING SYSTEM1992-06-10

Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.