DeviceClearance

TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T— 510(k) K082636

Substantially Equivalent

Quality Electrodynamics

FDA 510(k) clearance K082636 for TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T, Substantially Equivalent on 2008-09-25. Applicant: Quality Electrodynamics. Device class: 2.

Clearance details

Applicant
Quality Electrodynamics
Product code
Code MOS
Device class
Class 2
Regulation
21 CFR 892.1000
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mayfield Village, OH, US
Download summary PDFView on FDA.gov ↗

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Recalls naming K082636

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 K082636.

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