PMDA device listing
Ｘ線ＣＴ組合せ型ポジトロンＣＴ装置Ｏｐｔｉｍａ ＰＥＴ
PMDA Medical device listing · 221ACBZX00029000 · Class II
Key facts
| PMDA document key | 530979_221ACBZX00029000_H_01 |
|---|---|
| Brand names | Ｘ線ＣＴ組合せ型ポジトロンＣＴ装置Ｏｐｔｉｍａ ＰＥＴ, ＣＴ ５００，Ｄｉｓｃｏｖｅｒｙ ＰＥＴ, ＣＴ ６００（Ｏｍｎｉ Ｌｅｇｅｎｄ グループ） |
| General names (JMDN) | X線CT組合せ型ポジトロンCT装置 |
| Product type | Medical device |
| Device class (Japan) | Class II |
| Approval, certification or notification number | 221ACBZX00029000 |
| JMDN codes | 70010010 |
| Category code | A1000 |
| Marketing authorization holder | 製造販売／GEヘルスケア・ジャパン株式会社 |
| Package insert date | Sep 14, 2026 |
| PMDA product page | pmda.go.jp |
| Package insert on pmda.go.jp | pmda.go.jp |
At a glance
- 1–9 Package insert revisions
- 1–9 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: