XCT 2000 L PQCT BONE DENSITOMETER— 510(k) K983273

Name: FDA 510(k) clearance K983273
Creator: U.S. Food and Drug Administration
Published: 1998-10-29

Substantially Equivalent

Medical Systems, Inc.

FDA 510(k) clearance K983273 for XCT 2000 L PQCT BONE DENSITOMETER, Substantially Equivalent on 1998-10-29. Applicant: Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Medical Systems, Inc.
Product code: Code KGI
Device class: Class 2
Regulation: 21 CFR 892.1170
Advisory panel: Radiology
Date received: 1998-09-17
Decision date: 1998-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Atkinson, WI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KGI

view all

More clearances from Medical Systems, Inc.

view all

K820402 — PATIENT FOLLOW-UP COMPUTER (PFC1982-03-12

Adverse events under product code KGI

product code KGI

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.