Sedecal
510(k) K103522
Sedecal is a medical device (FDA Class II; FDA product code IZL, System, X-Ray, Mobile) made by Sedecal., Sa., cleared under FDA 510(k) K103522 on 26 Jan 2011, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK103522 | Date26 Jan 2011 | StatusActive |
Official records
- FDA 510(k) database K103522
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IZL
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1720
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K103522
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| SEDECAL SPL-HF-2.0 | SPL-HF-2.0 | 08436046001770 | — | On the market |
| SEDECAL SPL-HF-4.0 | SPL-HF-4.0 | 08436046001787 | — | On the market |
| SEDECAL SPL-HF-8.0 | SPL-HF-8.0 | 08436046001794 | — | No longer on the market |
| SEDECAL SPSL-HF-4.0 | SPSL-HF-4.0 | 08436046001824 | — | On the market |
| SEDECAL SPSL-HF-4.0-APR | SPSL-HF-4.0-APR | 08436046001848 | — | On the market |
| SEDECAL SPSL-HF-8.0 | SPSL-HF-8.0 | 08436046001831 | — | No longer on the market |
| SEDECAL SPSL-HF-8.0-APR | SPSL-HF-8.0-APR | 08436046001855 | — | No longer on the market |
Similar devices
Other devices filed under FDA product code IZL (System, X-Ray, Mobile).
- CAP-MOBILE by Philips Medical Systems (Cleveland), Inc.
- AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) by Poskom Co., Ltd.
- GM85 by Samsung Electronics Co.,Ltd
- SOYEE PORTABLE X-RAY UNIT, MODEL SY-HF-110 by Soyee Product, Inc.
- AJEX 1200 H / AJEX 240H MOBILE X-RAY GENERATOR by AJEX Meditech Ltd
- MX MOBILE X-RAY SYSTEM by Philips Medical Systems (Cleveland), Inc.
- Optima XR240amx by GE Medical Systems, LLC
- INCLINOMETER, VERMONT by Associates IN Radiology, Inc.
- X-RAY UNIT, PORTABLE GX-101 AEC by General X-Ray, Inc.
- PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS by Prognosys Medical Systems Private Limited