FDA 510(k) Applications for Medical Device:
Analyzer,Medical Image
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K243831 | AZmed |
10 Rue d'UzΦs | Paris | 75002 | |
| K241725 | Better Diagnostics AI Corp |
29 Alcott Way | Avon | CT | 06001 |
| K242437 | Cube Click, Inc. |
105 East 34 Street | New York | NY | 10016 |
| K231001 | DeepTek Medical Imaging Pvt Ltd |
3rd Floor, Ideas to Impact, Pallod Farms 3 | Pune | 411405 | |
| K230144 | Denti.AI Technology, Inc. |
99 Yorkville Ave, Suite 214 | Toronto | M5R3k5 | |
| K243239 | Exo Inc |
4201 Burton Drive | Santa Clara | CA | 95054 |
| K241620 | Gleamer SAS |
47bis rue des Vinaigriers | Paris | 75010 | |
| K213353 | Imagen Technologies, Inc |
151 West 26th Street, Suite 1001 | New York | NY | 10001 |
| K210666 | Imagen Technologies, Inc |
151 West 26th Street, Suite 1001 | New York | NY | 10001 |
| K223811 | Imagen Technologies, Inc |
594 Broadway, Suite 701 | New York | NY | 10012 |
| K230085 | Imagen Technologies, Inc |
594 Broadway, Suite 701 | New York | NY | 10012 |
| K223133 | Imidex Inc. |
3513 Brighton Blvd., Suites 456 7 454 | Denver | CO | 80216 |
| K221921 | Nobel Biocare AB |
Vastra Hamngatan 1 | 411 17 Goteborg | 402 26 | |
| K220928 | Overjet Inc. |
560 Harrison Ave., Unit 403 | Boston | MA | 02118 |
| K233738 | Overjet, Inc |
50 Milk Street, 16th Floor | Boston | MA | 02109 |
| K231678 | Overjet, Inc |
560 Harrison Ave #403 | Boston | MA | 02118 |
| K212519 | Overjet, Inc. |
560 Harrison Ave, Unit 403 | Boston | MA | 02118 |
| K222746 | Overjet, Inc. |
560 Harrison St., Unit 403 | Boston | MA | 02118 |
| K210365 | Pearl Inc. |
2515 Benedict Canyon Drive | Beverly Hills | CA | 90210 |
| K242522 | Pearl Inc. |
2515 Benedict Canyon Dr. | Beverly Hills | CA | 90210 |
| K242600 | Pearl Inc. |
2515 Benedict Canyon Dr. | Beverly Hills | CA | 90210 |
| K243234 | Pearl Inc. |
2515 Benedict Canyon Dr. | Beverly Hills | CA | 90210 |
| K243893 | Pearl, Inc. |
2515 Benedict Canyon Dr. | Beverly Hills | CA | 90210 |
| K231805 | Qure.ai Technologies |
Level 7, Commerz II, International Business Park | Mumbai | 400063 | |
| K201560 | Samsung Electronics Co.,Ltd. |
129, Samsung-Ro, Yeongtong-Gu | Suwon-Si | 16677 | |
| K240003 | Velmeni Inc. |
333 West Maude Avenue | Sunnyvale | CA | 94085 |
| K213795 | VideaHealth, Inc |
19 Kingston St | Boston | MA | 02111 |
| K232384 | VideaHealth, Inc. |
179 South Street Floor 5 | Boston | MA | 02111 |
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