The following data is part of a premarket notification filed by Iba Dosimetry Gmbh with the FDA for Blue Phantom Pt.
| Device ID | K191821 |
| 510k Number | K191821 |
| Device Name: | Blue Phantom PT |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | IBA Dosimetry GmbH Bahnhofstr. 5 Schwarzenbruck, DE 90592 |
| Contact | Andreas Suchi |
| Correspondent | Olaf Teichert TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-07-08 |
| Decision Date | 2020-01-23 |
| Summary: | summary |