FDA 510(k) Applications for Medical Device:
Cabinet,X-Ray System
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K091928 | BIOPTICS, INC. |
3440 E BRITANNIA DR | TUCSON | AZ | 85743 |
| K091558 | BIOPTICS, INC. |
3440 E BRITANNIA DR | TUCSON | AZ | 85743 |
| K082432 | BIOPTICS, INC. |
15546 W. GELDING DR. | SURPRISE | AZ | 85379 |
| K052433 | BIOPTICS, INC. |
3496 S. DODGE BLVD., SUITE 110 | TUCSON | AZ | 85713 |
| K193317 | Cirdan Imaging Limited |
8 Enterprise Crescent, Ballinderry Road | Lisburn | BT28 2BP | |
| K213691 | Cirdan Imaging Ltd |
The Green, Tullynacross Rd, Lambeg | Lisburn | BT27 5SR | |
| K192939 | Clarix Imaging |
2242 Harrison St Suite 201 | Chicago | IL | 60612 |
| K202713 | CompAI Healthcare (Shenzhen) Co.,ltd |
8B, Huangting Building, No.355, Fuhua Road,Futian Street, | Shenzhen | 518026 | |
| K230136 | CompAI Healthcare (Suzhou) Co.,ltd |
Room 3A05, Building 2, No.8 Changting Road, High-tech Zone | Suzhou | 215151 | |
| K230140 | CompAI Healthcare (Suzhou) Co.,ltd |
Room 3A05, Building 2, No.8 Changting Road, High-tech Zone | Suzhou | 215151 | |
| K153583 | FAXITRON BIOPTICS LLC |
3440 E. BRITANNIA DRIVE | TUCSON | AZ | 85743 |
| K170786 | Faxitron Bioptics LLC |
3440 E. Britannia Dr. | Tucson | AZ | 85706 |
| K122428 | FAXITRON BIOPTICS LLC |
3440 E. BRITANNIA DRIVE | TUCSON | AZ | 85706 |
| K173309 | Faxitron Bioptics Llc |
3440 E. Britannia Dr. | Tucson | AZ | 85706 |
| K183142 | Faxitron Bioptics LLC |
3440 E. Britannia Dr., Suite 150 | Tucson | AZ | 85706 |
| K061361 | FAXITRON X-RAY CORP. |
225 LARKIN DR.,SUITE 1 | WHEELING | IL | 60090 |
| K072557 | FAXITRON X-RAY CORP. |
225 LARKIN DR.,SUITE 1 | WHEELING | IL | 60090 |
| K021113 | FISCHER IMAGING CORP. |
12300 NORTH GRANT ST. | DENVER | CO | 80241-3120 |
| K182727 | Hologic, Inc. |
36 Apple Ridge Road | Danbury | CT | 06810 |
| K111508 | HOLOGIC, INC. |
35 CROSBY DR. | BEDFORD | MA | 01730 |
| K071233 | KUB TECHNOLOGIES, INC |
543 LONG HILL AVENUE | SHELTON | CT | 06824 |
| K210957 | KUB Technologies, Inc. |
111 Research Drive | Stratford | CT | 06615 |
| K183624 | KUB Technologies, Inc. |
111 Research Drive | Stratford | CT | 06615 |
| K210956 | KUB Technologies, Inc. |
111 Research Drive | Stratford | CT | 06615 |
| K200756 | KUB Technologies, Inc. |
111 Research Drive | Stratford | CT | 06615 |
| K210955 | KUB Technologies, Inc. |
111 Research Drive | Stratford | CT | 06615 |
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