PMDA device listing

携帯型X線撮影装置 PX-20BTmini

PMDA Medical device listing · 227AGBZX00062000 · Class II

Key facts

PMDA document key 201097_227AGBZX00062000_A_01
Brand names 携帯型X線撮影装置 PX-20BTmini
General names (JMDN) ポータブルアナログ式汎用一体型X線診断装置
Product type Medical device
Device class (Japan) Class II
Approval, certification or notification number 227AGBZX00062000
JMDN codes 37642020
Category code A0909
Marketing authorization holder 製造販売/株式会社ケンコー・トキナーメディカルイメージング部太子工場
Package insert date Oct 13, 2022
PMDA product page pmda.go.jp
Package insert on pmda.go.jp pmda.go.jp

At a glance

  • 1–9 Package insert revisions
  • None Related PMDA documents
  • Listed Listed on the PMDA site
  • Yes Refers to a technical manual

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About PMDA medical device and IVD listings (Japan)

Medical devices and in vitro diagnostics sold in Japan are approved by the MHLW, certified by a registered certification body or notified, depending on class, and the PMDA publishes each product's package insert. Only identifiers, names and dates are shown here; package insert text and review reports are not reproduced.

Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, medical device package insert database · Source date:

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