PMDA device listing

X線平面検出器 TFP−4600A

PMDA Medical device listing · 09B1X00003000003 · Class I

Key facts

PMDA document key 480122_09B1X00003000003_A_01
Brand names X線平面検出器 TFP−4600A
General names (JMDN) X線平面検出器
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 09B1X00003000003
JMDN codes 70029000
Category code A0900
Marketing authorization holder 製造販売/東芝メディカルシステムズ株式会社
Package insert date Nov 29, 2006
Latest revision 2006-09
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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