PMDA device listing
多目的X線撮影システムＩＮＮＯＶＡ（ＩＧＳ５２０
PMDA Medical device listing · 21500BZY00327000 · Class II
Key facts
| PMDA document key | 530979_21500BZY00327000_B_01 |
|---|---|
| Brand names | 多目的X線撮影システムＩＮＮＯＶＡ（ＩＧＳ５２０, ＩＧＳ５３０, ＩＧＳ５４０, ＩＧＳ５, ２１００, ２１００ Ｏｐｔｉｍａ Ｅｄｉｔｉｏｎ, ３１００, ３１００ Ｏ |
| General names (JMDN) | 据置型デジタル式循環器用X線透視診断装置 |
| Product type | Medical device |
| Device class (Japan) | Class II |
| Approval, certification or notification number | 21500BZY00327000 |
| JMDN codes | 37623000 |
| Category code | A0900 |
| Marketing authorization holder | 製造販売／GEヘルスケア・ジャパン株式会社 |
| Package insert date | Feb 10, 2023 |
| 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: