GM60A-32S, GM60A-40S
FDA 510(k) K142492 · Samsung Electronics Co., Ltd.
510(k) numberK142492
Submission
- Device name
- GM60A-32S, GM60A-40S
- Applicant
- Samsung Electronics Co., Ltd.
Suwon-Si, Gyeonggi-Do, KR - Received
- September 4, 2014
- Decision date
- December 17, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IZL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260236 | XliteIZL · Traditional | Gemss Healthcare Co., Ltd. | 08/03/2026SE |
| K253058 | Portable DR Imaging SystemIZL · Traditional | Shantou Institute of Ultrasonic Instruments Co.… | 06/18/2026SE |
| K260085 | RAYMO Mobile X-ray System (Model: RAYMO)IZL · Traditional | DRGEM Corporation | 05/14/2026SE |
| K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemIZL · Traditional | Carestream Health | 03/11/2026SE |
| K253244 | AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)IZL · Traditional | Poskom Co., Ltd. | 02/23/2026SE |
| K250976 | Airbile-100IZL · Traditional | Poskom Co., Ltd. | 12/19/2025SE |
| K251710 | Mobile X-ray unit (!M1)IZL · Traditional | Solutions For Tomorrow AB | 10/24/2025SE |
| K243864 | BONX805IZL · Traditional | Bontech Co., Ltd. | 09/12/2025SE |
| K251443 | PromoIZL · Traditional | DRGEM Corporation | 08/22/2025SE |
| K251223 | HnX-P1, HnX-PBIZL · Traditional | H&abyz Co., Ltd. | 08/04/2025SE |
More from H&abyz Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260481 | GC85AKPR · Traditional | 08/27/2026SE |
| K261187 | Hearing Aid FeatureSCR · Traditional | 07/31/2026SE |
| K261011 | Sleep Apnea Feature (v2.0)QZW · Traditional | 07/20/2026SE |
| K242651 | GM85IZL · Special | 10/01/2024SE |
| K242478 | GF85 (models GF85-3P, GF85-SP)KPR · Traditional | 09/19/2024SE |
| K240909 | Samsung ECG App v 1.3 (ECG)QDA · Traditional | 08/02/2024SE |
| K230292 | Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationQDA · Traditional | 05/02/2023SE |
| K222353 | GM85IZL · Traditional | 09/29/2022SE |
| K220175 | GM85IZL · Traditional | 04/21/2022SE |
| K213452 | Gems-HPHL · Traditional | 04/21/2022SE |
Questions and answers
When was GM60A-32S, GM60A-40S cleared by the FDA?
GM60A-32S, GM60A-40S (K142492) received a 510(k) decision of Substantially Equivalent on December 17, 2014, 104 days after the submission was received.
What is the product code of K142492?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.