FDA 510(k) Applications for Medical Device:
System, Radiation Therapy, Radionuclide
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K000478 | ACCURAY, INC. |
570 DEL REY AVE. | SUNNYVALE | CA | 94085 |
| K984563 | ACCURAY, INC. |
570 DEL REY AVE. | SUNNYVALE | CA | 94085 |
| K190844 | Akesis Inc |
5129 Commercial Circle | Concord | CA | 94520 |
| K203146 | Akesis Inc |
5129 Commercial Circle | Concord | CA | 94520 |
| K200050 | Akesis Inc |
5129 Commercial Circle | Concord | CA | 94520 |
| K060314 | AMERICAN RADIOSURGERY, INC. |
16787 BERNARDO CENTER DRIVE | SAN DIEGO | CA | 92128 |
| K142219 | Best Theratronics Limited |
413 March Road | Ottawa | k2k 0e4 | |
| K150191 | Best Theratronics Limited |
413 March Road | Ottawa | k2k 0e4 | |
| K092083 | ELEKTA INSTRUMENT AB |
KUNGSTENSGATAN 18 | STOCKHOLM | S-103 93 | |
| K051022 | ELEKTA INSTRUMENT AB |
KUNGSTENSGATAN 18 | STOCKHOLM | SE-103 93 | |
| K151561 | ELEKTA INSTRUMENT AB |
KUNGSTENSGATAN 18 | STOCKHOLM | 10393 | |
| K160440 | Elekta Instrument AB |
Kungstensgatan 18 | Stockholm | 10393 | |
| K151159 | ELEKTA INSTRUMENT AB |
KUNGSTENSGATAN 18 | STOCKHOLM | 10393 | |
| K120811 | ELEKTA INSTRUMENT AB |
KUNGSTENSGATAN 18 | STOCKHOLM | S-103 93 | |
| K133565 | ELEKTA INSTRUMENT AB |
KUNGSTENSGATAN 18 | STOCKHOLM | S-103 93 | |
| K063512 | ELEKTA INSTRUMENT AB |
KUNGSTENSGATAN 18 | STOCKHOLM | SE-103 93 | |
| K173789 | Elekta Instrument AB |
Kungstensgatan 18 | Stockholm | 10393 | |
| K061941 | ELEKTA INSTRUMENT AB |
KUNGSTENSGATAN 18 | STOCKHOLM | S-103 93 | |
| K984328 | ELEKTA INSTRUMENT AB |
18140 SMOKESIGNAL DR. | SAN DIEGO | CA | 92127 |
| K173791 | Elekta Instrument AB |
Kungstensgatan 18 | Stockholm | 10393 | |
| K061540 | ELEKTA INSTRUMENT AB |
KUNGSTENSGATAN 18 | STOCKHOLM | S-103 93 | |
| K222047 | Elekta Solutions AB |
Kungstensgatan 18 Box 7593 | Stockholm | SE-10393 | |
| K131777 | HYPER TECHNOLOGY INC |
P.O. BOX 120-119 | SHANGHAI | 200120 | |
| K041125 | MASEP MED SCIENCE & TECH. DEVELOPMENT (SHENZHEN) C |
55 NORTHERN BLVD., STE 200 | GREAT NECK | NY | 11021 |
| K102533 | MASEP MEDICAL SCIENCE & TECH.DEVELOPMENT (SHENZHEN |
55 NORTHREN BLVD | GREAT NECK | NY | 11021 |
| K001006 | MDS NORDION |
447 MARCH RD. | OTTAWA, ONTARIO | K2K1X8 | |
| K053485 | MDS NORDION INC. |
447 MARCH ROAD | OTTAWA, ONTARIO | K2K 1X8 | |
| K960892 | NOVA THERAPEUTIC SYSTEM |
2004 LE DROIT DR. | SOUTH PASADENA | CA | 91030 |
| K970647 | OUR SCIENTIFIC INTL., INC. |
55 NORTHERN BLVD. | NEW YORK | NY | 11021 |
| K203250 | Our United Corporation |
Room 10301, 3rd Floor, Unit 1, Block 28, ShouChuang | Xi'an | 710018 | |
| K973441 | PATTERSON CONSULTING GROUP, INC. |
18140 SMOKESIGNAL DR. | SAN DIEGO | CA | 92127 |
| K964606 | THERATRONICS, INC. |
413 MARCH ROAD | KANATA ONTARIO | K2K 2B7 | |
| K983917 | THERATRONICS, INC. |
413 MARCH ROAD | KANATA ONTARIO | K2K 2B7 | |
| K180571 | Xcision Medical Systems, LLC |
9176 Red Branch Road | Columbia | MD | 21045 |
| K172706 | Xcision Medical Systems, LLC |
9176 Red Branch Road, Suite O | Columbia | MD | 21045 |
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