The AIO Solution

510(k) Number

K191158 ↗

FDA product code

IYE

FDA applicant

Orfit Industries NV

Device class

Class II

Regulation

21 CFR Part 892.5050

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

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.

Other devices filed under FDA product code IYE (Accelerator, Linear, Medical).

• KLARITY MEDICAL R7214-30C by Klarity Medical Products, LLC
• Peacock System by Nomos Corp.
• Orfit Industries 32042 by Orfit Industries NV
• Super Tissue by I.Z.I. Corp.
• XKNIFE-4 by Radionics, Inc.
• Klarity by Larson Products, Inc.
• Planet Thermoplastic Immobilization System by S & S X-Ray Products, Inc.
• Pseudo-Patient by Rtsafe, Inc.
• MEVASSIST(SETUP CONTROLLER) by Magus Microcontrollers, Inc.
• SOFTDISO by Best Nomos

• Arm positioning system for LEO chair

  Class I

  CE/MDR

• Belt for LEO chair

  Class I

  CE/MDR

• Backrest for LEO chair - Rectangular

  Class I

  CE/MDR

• AIO 3.0 Knee & Leg immobilisation Cush.

  Class I

  CE/MDR

See all devices from Orfit Industries →