SII 525 MS— 510(k) K945709

Name: FDA 510(k) clearance K945709
Creator: U.S. Food and Drug Administration
Published: 1994-12-14

Substantially Equivalent

Scott Imaging Intl., Inc.

FDA 510(k) clearance K945709 for SII 525 MS, Substantially Equivalent on 1994-12-14. Applicant: Scott Imaging Intl., Inc.. Device class: 2.

Clearance details

Applicant: Scott Imaging Intl., Inc.
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 1994-11-21
Decision date: 1994-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mobile, AL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Scott Imaging Intl., Inc.

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K946260 — NTBS-1417, 1436, TBS-14171995-03-31
K950040 — SII 525 APR1995-03-21
K950041 — SII 360 APR1995-03-21
K946261 — MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 50001995-02-15
K946262 — EURO, SCST, SCCFT ATLAS RADIOLOGIC TABLES1995-02-15

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.