Bragg peak Thin-window Bragg peak chamber 10.5 cm³
by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH 3 variants
Bragg peak Thin-window Bragg peak chamber 10.5 cm³ (TM34080-2,5) is an ionization chamber radiation measuring probe (FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH, cleared under FDA 510(k) K961208 on 17 Jun 1996 and listed in FDA GUDID since 26 Apr 2017 (UDI-DI EPTWTM34080Y2Z50), active as of 23 Oct 2026.
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberEPTWTM34080Y2Z50 | Date26 Apr 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK961208 | Date17 Jun 1996 | StatusActive |
Official records
- FDA 510(k) database K961208
Across registries
- FDA 510(k) K961208 decided 17 Jun 1996 Active
- FDA GUDID UDI-DI EPTWTM34080Y2Z50 listed 26 Apr 2017 Listed
Timeline
- Cleared FDA 510(k) K961208
- Listed FDA GUDID EPTWTM34080Y2Z50
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bragg peak
- Generic name
- Ionization chamber radiation measuring probe
- Model / Ref / Catalog
- Thin-window Bragg peak chamber 10.5 cm³, TM34080-2, 5
- Primary DI / UDI-DI
- EPTWTM34080Y2Z50
- 510(k) Number
- FDA product code
- IYE
- GMDN term
- Ionization chamber radiation measuring probe
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- In Commercial Distribution
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Other devices filed under Ionization chamber radiation measuring probe.
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