This page includes the latest FDA filings for Iba Dosimetry G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 9614952 |
| FEI Number | 3006653576 |
| Name | Nick Narloch |
| Owner & Operator | IBA Dosimetry GmbH |
| Contact Address | BAHNHOFSTRASSE 5 -- SCHWARZENBRUCK DE-BY Bayern D-90592 DE |
| Official Correspondent |
|
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 3150 Stage Post Dr., Suite 110 Bartlett, TN 38133 US |
| Establishment Type | Manufacture Medical Device |
| Registration Number | 1062572 |
| FEI Number | 3001238439 |
| Name | IBA Dosimetry America |
| Owner & Operator | IBA Dosimetry GmbH |
| Contact Address | BAHNHOFSTRASSE 5 -- SCHWARZENBRUCK DE-BY Bayern D-90592 DE |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 3150 STAGE POST DR., STE. 110 BARTLETT, TN 38133 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
| IBA Dosimetry GmbH | myQA® SRS Phantom Cyberknife SR02-001 | 2023-10-18 |
| IBA Dosimetry GmbH | Lift table HA03-010#004 | 2023-09-27 |
| IBA Dosimetry GmbH | Lift table HA03-000#004 | 2023-09-27 |
| IBA Dosimetry GmbH | Water Reservoir HA05-010 | 2023-08-11 |
| IBA Dosimetry GmbH | Water Reservoir HA05-000 | 2023-08-11 |
| IBA Dosimetry GmbH | myQA SRS Detector Cyberknife edition SR01-100 | 2023-08-02 |
| IBA Dosimetry GmbH | DOSE-X DX00-100 | 2023-04-21 |
| IBA Dosimetry GmbH | DOSE-X DX00-000 | 2023-04-21 |
| IBA Dosimetry GmbH | Lift table HA03-230 | 2023-04-20 |
| IBA Dosimetry GmbH | Lift table HA03-115 | 2023-04-20 |
| IBA Dosimetry GmbH | CCU Steuerelektronik PT | 2023-04-20 |
| IBA Dosimetry GmbH | miniPhantom BS50-500 | 2023-04-20 |
| IBA Dosimetry GmbH | KermaX-plus 120-210 | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-206 S | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-206 | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-205 TINO | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-205 S | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-205 | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-160 MFD | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-160 LFD | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-160 EAS | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-140 XCAN | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-132 MG | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-132 | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131ZKCANTIN | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131ZK CAN | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131 TINO | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131RSZKO | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131RSZKHS | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131 RS-ZK | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131 P | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131OEM HS | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131 OEM | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131 IS HS | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131 IS | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131 HS E | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131 HS | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131 ETH | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131 E | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131CAN TINO | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131 AIR | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131 MICRO | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131 MICRO | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131 MICRO | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131OEM CAN | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131OEM CAN | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131ZKCANO | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131ZKCANO | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131ZKCANO | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131OEM CAN | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131OEM CAN | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131OEM CAN | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131OEM CAN | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131 MIC CAN | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131 MIC CAN | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131 HS/RS485 | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131 HS/RS485 | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-131 HS/RS485 | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-130 CAN | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-130 CAN | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-130 CAN | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-130 HS/RS485 | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-130 | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-126 TINO | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-126 PH TINO | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-126HS/RS485 | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-126 GE TINO | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-126C WH | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-126C GR | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-126C EL | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-126C CO | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-126C | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-125C | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-123C | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-122C IMD | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-122C GMM | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-122C BV29 | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-122C BV25 | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-122C | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-121CPLENO | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-121C | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-104 TINO | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-104 MICRO | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-104 HS T | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-104 HS E | 2021-12-27 |
| IBA Dosimetry GmbH | KermaX-plus 120-104 HS | 2021-12-27 |
| IBA Dosimetry GmbH | myQA FastTrack PT | 2021-10-21 |
| IBA Dosimetry GmbH | miniPhantom R | 2021-05-26 |
| IBA Dosimetry GmbH | myQA® SRS Phantom | 2021-04-15 |
| IBA Dosimetry GmbH | miniPhantom R | 2021-04-15 |
| IBA Dosimetry GmbH | myQA® SRS Detector | 2021-04-15 |
| IBA Dosimetry GmbH | Gantry Sensor + | 2021-04-15 |
| IBA Dosimetry GmbH | MatriXX Resolution | 2021-04-15 |
| IBA Dosimetry GmbH | Dosimeter Dosimax plus A HV VD0201790 | 2020-11-03 |
| IBA Dosimetry GmbH | Dosimeter Dosimax plus I VD0201748 | 2020-11-03 |
| IBA Dosimetry GmbH | Dosimeter Dosimax plus A VD0201747 | 2020-11-03 |
| IBA Dosimetry GmbH | Dosimeter Dosimax plus VD0201740 | 2020-11-03 |
| IBA Dosimetry GmbH | Dosimeter Dosimax plus duo VD0201460 | 2020-11-03 |
| IBA Dosimetry GmbH | Multimeter MagicMaX Universal PT with special calibration DP0202010 | 2020-11-03 |
| IBA Dosimetry GmbH | Multimeter MagicMax PT - rad/flu/dent with special calibtation DP0201940 | 2020-11-03 |
IBA Dosimetry GmbH | MyQA ION | 2020-07-17 |
Nick Narloch [IBA Dosimetry GmbH] | Blue Phantom PT | 2020-01-27 |
IBA Dosimetry America [IBA Dosimetry GmbH] | Blue Phantom PT | 2020-01-27 |
IBA Dosimetry GmbH | Blue Phantom PT | 2020-01-23 |
Nick Narloch [IBA Dosimetry GmbH] | myQA Cockpit | 2015-06-09 |
Nick Narloch [IBA Dosimetry GmbH] | incl Water Phantom, MatriXX PT and Software | 2012-07-12 |
Nick Narloch [IBA Dosimetry GmbH] | DigiPhant PT | 2012-07-12 |
Nick Narloch [IBA Dosimetry GmbH] | OmniPro Incline | 2009-11-26 |
IBA DOSIMETRY GMBH | OMNIPRO INCLINE | 2009-09-18 |
Nick Narloch [IBA Dosimetry GmbH] | DPD-12PC | 2008-01-03 |
Nick Narloch [IBA Dosimetry GmbH] | RFA-300 UTILITY | 2008-01-03 |
Nick Narloch [IBA Dosimetry GmbH] | Blue Phantom WP700 | 2008-01-03 |
Nick Narloch [IBA Dosimetry GmbH] | Blue Phantom 2, Blue Phantom Helix, Blue Phantom Compact, Blue Phantom SmartScan | 2008-01-03 |
Nick Narloch [IBA Dosimetry GmbH] | DPD-3 | 2008-01-03 |
Nick Narloch [IBA Dosimetry GmbH] | RFA A-300 | 2008-01-03 |
Nick Narloch [IBA Dosimetry GmbH] | Compass | 2008-01-03 |
Nick Narloch [IBA Dosimetry GmbH] | ONE DIMENSIONAL WATER PHANTOM, WP 1D | 2008-01-03 |
Nick Narloch [IBA Dosimetry GmbH] | OMNIPRO I'MRT | 2008-01-03 |
Nick Narloch [IBA Dosimetry GmbH] | myQA Accept | 2008-01-03 |
Nick Narloch [IBA Dosimetry GmbH] | with different Ionization chambers (e.g. FC65-P, PPC40) | 2008-01-03 |
Nick Narloch [IBA Dosimetry GmbH] | Dose 1 | 2008-01-03 |
Nick Narloch [IBA Dosimetry GmbH] | SMfit | 1999-09-29 |
Nick Narloch [IBA Dosimetry GmbH] | QA Crosschecker | 1999-09-29 |
Nick Narloch [IBA Dosimetry GmbH] | KermaX | 1999-09-29 |
Nick Narloch [IBA Dosimetry GmbH] | miniPhantom | 1994-11-15 |
Nick Narloch [IBA Dosimetry GmbH] | Solid Phantoms (SP22, SP33, SP34) | 1994-11-15 |
| NCAGE Code | CA157 | IBA DOSIMETRY GMBH |
| NCAGE Code | C3812 | IBA DOSIMETRY GMBH |
| CAGE Code | C3812 | IBA DOSIMETRY GMBH |
| CAGE Code | CA157 | IBA DOSIMETRY GMBH |