FDA 510(k) Applications for Medical Device:
Lung Computed Tomography System, Computer-Aided Detection
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K192880 | Beijing Infervision Technology Co.,Ltd. |
Haidian District | Beijing | 100085 | |
| K221592 | Coreline Soft Co.,Ltd. |
4,5F(Yeonnam-dong), 49, World Cup buk-ro 6-gil, Mapo-gu | Seoul | 03991 | |
| K042694 | GE MEDICAL SYSTEMS |
3000 NORTH GRANDVIEW BLVD. | WAUKESHA | WI | 53188 |
| K043617 | HOLOGIC, INC. |
35 CROSBY DR. | BEDFORD | MA | 01730 |
| K240554 | Infervision Medical Technology Co., Ltd. |
Room B401, 4th Floor, Building 1, No.12 Shangdi | Beijing | ||
| K041807 | MEDICSIGHT |
46 BERKELEY SQUARE | LONDON | W 1J 5AT | |
| K033412 | MEDICSIGHT |
46 BERKELEY SQUARE | LONDON | W 1J 5AT | |
| K201501 | MeVis Medical Solutions AG |
Caroline-Herschel-Strasse 1 | Bremen | 28359 | |
| K041380 | R2 TECHNOLOGY, INC. |
1195 W. FREMONT AVE. | SUNNYVALE | CA | 94087 |
| K221612 | Riverain Technologies, Inc. |
3130 South Tech Blvd. | Miamisburg | OH | 45342-4860 |
| K161201 | RIVERAIN TECHNOLOGIES, LLC |
3020 SOUTH TECH BLVD. | Miamisburg | OH | 45324 |
| K143196 | SIEMENS AG MEDICAL SOLUTIONS |
20 VALLEY STREAM PARKWAY | MALVERN | PA | 19355 |
| K033374 | SIEMENS AG, MEDICAL SOLUTIONS |
SIEMENSSTRASSE 1 | FORCHHEIM | D 91301 | |
| K203258 | Siemens Healthcare GmbH |
Siemensstr. 1 | Forchheim | 91301 | |
| K231157 | Siemens Healthcare GmbH |
Siemensstr. 1 | Forchheim | 91301 | |
| K063877 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
51 VALLEY STREAM PKWY. | MALVERN | PA | 19355-1406 |
| K193216 | Siemens Medical Solutions, Inc |
65 Valley Stream Parkway | Malvern | PA | 19355 |
| K242919 | V5med Inc. |
7F., No. 36, Chenggong 12th St., Zhubei City | Hsinchu County | 302050 |
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