AeroDR SYSTEM 2— 510(k) K151465

Substantially Equivalent

Konica Minolta, Inc.

FDA 510(k) clearance K151465 for AeroDR SYSTEM 2, Substantially Equivalent on 2015-06-29. Applicant: Konica Minolta, Inc.. Device class: 2.

Clearance details

Applicant: Konica Minolta, Inc.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2015-06-01
Decision date: 2015-06-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Hino-Shi, JP

Download summary PDF View on FDA.gov ↗

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Recalls naming K151465

K-number listed on FDA's recall record

Z-2281-2018 — CS-7, Model No. A4C1Class II·Terminated·Konica Minolta Medical Imaging USA, Inc.·20180509

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151465.

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