DPX BONE DENSITOMETER— 510(k) K873296

Substantially Equivalent

Lunar Radiation Corp.

FDA 510(k) clearance K873296 for DPX BONE DENSITOMETER, Substantially Equivalent on 1988-06-06. Applicant: Lunar Radiation Corp.. Device class: 2.

Clearance details

Applicant
Lunar Radiation Corp.
Product code
Code KGI
Device class
Class 2
Regulation
21 CFR 892.1170
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Madison, WI, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KGI

product code KGI
Other
1
Total
1

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

Recalls naming K873296

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K873296.

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