SONY CINE VIDEO SYSTEM SME-3300— 510(k) K884008

Name: FDA 510(k) clearance K884008
Creator: U.S. Food and Drug Administration
Published: 1988-11-30

Substantially Equivalent

Sony Medical Electronics Co.

FDA 510(k) clearance K884008 for SONY CINE VIDEO SYSTEM SME-3300, Substantially Equivalent on 1988-11-30. Applicant: Sony Medical Electronics Co.. Device class: 2.

Clearance details

Applicant: Sony Medical Electronics Co.
Product code: Code IZI
Device class: Class 2
Regulation: 21 CFR 892.1600
Advisory panel: Radiology
Date received: 1988-09-21
Decision date: 1988-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IZI

view all

K261037 — 780 nm SPY Portable Handheld Imaging (SPY-PHI) System2026-05-28
K253181 — SURGIMAGE SIM 1000H Fluorescence Imaging Platform2026-05-13
K243645 — IC-Flow Imaging System 2.02025-09-22
K243077 — Affirm 8002025-06-27
K231986 — Modus IR2024-03-25

More clearances from Sony Medical Electronics Co.

view all

K980279 — SONY DXC-LS1 COLOR VIDEO CAMERA1998-04-24
K913886 — SONY DVR-10 DIGITAL VIDEOCASSETTE RECORDER1992-01-24
K904447 — SONY CINE VIDEO SYSTEM SME-35001990-10-17
K902535 — SONY WBS-700H VIDEOCASSETTE RECORDER SYSTEM1990-06-29
K901153 — SONY VO-5800H VIDEOCASSETTE RECORDER1990-04-19

Adverse events under product code IZI

product code IZI

Death: 9
Malfunction: 5,312
Total: 5,321

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.