FDA 510(k) Applications for Medical Device:
System, X-Ray, Tomographic
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K193262 | Agfa N.V. |
Septestraat 27 | Mortsel | B-2640 | |
| K183275 | Agfa N.V. |
Septestraat 27 | Mortsel | B-2640 | |
| K121499 | FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
419 WEST AVE. | STAMFORD | CT | 06902-6300 |
| K132261 | GE MEDICAL SYSTEMS, LLC |
3000 N GRANDVIEW BLVD. | WAUKESHA | WI | 53188 |
| K213081 | General Medical Merate S.P.A |
Via Partigiani, 25 | Seriate | 24068 | |
| K013620 | MEDSTONE INTL., INC. |
100 COLUMBIA, SUITE 100 | ALISO VIEJO | CA | 92656-4114 |
| K242395 | Nano-x Imaging Ltd. |
94 Em Hamoshavot Road, Brosh building, | Petah Tikva | 4970602 | |
| K222934 | Nano-X Imaging Ltd. |
Communications Center, Bldg. C, Entrance 1 | Neve Ilan | 9085000 | |
| K250850 | Nano-x Imaging Ltd. |
94 Em Hamoshavot Road, Brosh building, Ofer Tech Park, | Petah Tikva | 4970602 | |
| K973864 | PAUSCH CORP. |
808 SHREWSBURY AVE. | TENTON FALLS | NJ | 07724 |
| K973834 | PAUSCH CORP. |
808 SHREWSBURY AVE. | TENTON FALLS | NJ | 07724 |
| K221949 | Pausch Medical GmbH |
Graf-Zeppelin-Strabe 1 | Erlangen | D-91056 | |
| K011290 | XMAR CORP. |
2222 DELAWARE DR. | CLEVELAND HEIGHTS | OH | 44106-3115 |
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