STS(TM) FLUOROSCOPIC IMAGING MODULE— 510(k) K905278

Name: FDA 510(k) clearance K905278
Creator: U.S. Food and Drug Administration
Published: 1991-02-04

Substantially Equivalent

Medstone Intl., Inc.

FDA 510(k) clearance K905278 for STS(TM) FLUOROSCOPIC IMAGING MODULE, Substantially Equivalent on 1991-02-04. Applicant: Medstone Intl., Inc.. Device class: 2.

Clearance details

Applicant: Medstone Intl., Inc.
Product code: Code JAA
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 1990-11-23
Decision date: 1991-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JAA

view all

K253103 — Nexus DRF Digital X-ray Imaging System2026-05-29
K251650 — Insight Enhanced DRF (EN-1002-01)2025-09-16
K242488 — Soteria E-View2025-01-06
K242948 — Adora DRFi (04550010)2024-12-23
K233380 — TRIDENT Mobile Fluoroscopy System2024-06-26

More clearances from Medstone Intl., Inc.

view all

K013620 — MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION2002-01-22
K010900 — STS-T LITHOTRIPTER, MODEL STS-T2001-04-05

Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

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.