510(k) K201560
- Device
- Auto Lung Nodule Detection
- Applicant
- Samsung Electronics Co.,Ltd.
- 510(k) number
- K201560
- Product code
- MYN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-08-31
- Date received
- 2020-06-10
- Regulation
- 892.2070
- Classification name
- Analyzer, Medical Image
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jaesang Noh
- Address
- 129 Samsung-Ro, Yeongtong-Gu Suwon-Si KR 16677 16677
FDA Registration Numbers#
- 3014398772
- 3019544554
- 3021907554
- 3038187462
- 3022719380
- 3024891354
- 3038172231
- 1226003
- 9611992
- 3005383085
- 3012035824
- 3025110425
- 3021887566
- 3005496266
- 3026970882
- 3029904428
- 3043237021
- 3026753394
- 8020825
- 3010300212
- 3005739655
- 3008693672
- 3032960222
- 3029956998
- 3032116890
- 3005156333
- 3014661828
- 3017840913
Source Documents#
Other 510(k) Records For Product Code MYN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252953 | Velmeni for Dentists (V4D) Endo-Perio | Velmeni, Inc. | 2026-05-11 |
| K251934 | qXR-Detect | Qure.Ai Technologies | 2026-01-16 |
| K252934 | Diagnocat | DGNCT, LLC | 2026-01-15 |
| K253009 | DS Core Detect | Dentsply Sirona, Inc. | 2026-01-07 |
| K252086 | DTX Studio Assist | Nobel Biocare C/O Medicim NV | 2025-11-17 |
| K250525 | Second Opinion® Panoramic | Pearl, Inc. | 2025-11-14 |
| K250264 | SugarBug (1.x) | Bench7, Inc. | 2025-11-07 |
| K251002 | Videa Dental AI | Videahealth, Inc. | 2025-09-19 |
| K250753 | VELMENI for DENTISTS (V4D) | Velmeni, Inc. | 2025-09-02 |
| K243234 | Second Opinion® CS | Pearl, Inc. | 2025-06-12 |
| K242437 | Smile Dx® | Cube Click, Inc. | 2025-05-14 |
| K243893 | Second Opinion® Pediatric | Pearl, Inc. | 2025-05-05 |
| K243239 | Lung AI (LAI001) | Exo, Inc. | 2025-04-24 |
| K242600 | Second Opinion Periapical Radiolucency Contours | Pearl, Inc. | 2025-04-11 |
| K243831 | Rayvolve LN | AZmed | 2025-03-26 |
Legacy Summary#
summary
FDA Review#
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