M6-M
FDA 510(k) K930699 · X-Cel X-Ray Corp.
510(k) numberK930699
Submission
- Device name
- M6-M
- Applicant
- X-Cel X-Ray Corp.
Crystal Lake, IL, US - Received
- February 10, 1993
- Decision date
- August 9, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
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Questions and answers
When was M6-M cleared by the FDA?
M6-M (K930699) received a 510(k) decision of Substantially Equivalent on August 9, 1993, 180 days after the submission was received.
What is the product code of K930699?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.