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RW-1

by Mediott, Inc. 2 variants

510(k) K253029

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK253029 Date31 Mar 2026ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The RW-1 is a Class II X-ray system manufactured by Mediott, Inc. It is used in radiology for medical image management and processing.

The device is supplied as a single unit and is not specified as single-use or reusable. It has FDA 510(k) clearance with the number K253029 and product code LLZ. The device is not indicated as MRI safe.

Other devices from Mediott, Inc.

  • Rw-1

    Class II

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the RW-1 X-ray system used for?

    The RW-1 is a Class II X-ray system manufactured by Mediott, Inc. It is specifically designed for use in radiology departments for medical image management and processing.

  • Is the RW-1 X-ray system single-use or reusable?

    The RW-1 is supplied as a single unit and is not specified as either single-use or reusable in the device documentation.

  • What regulatory approvals does the RW-1 X-ray system have?

    The RW-1 has FDA 510(k) clearance with number K253029 and product code LLZ. It was determined to be substantially equivalent to predicate devices.

  • Is the RW-1 X-ray system MRI safe?

    The device documentation does not indicate that the RW-1 X-ray system is MRI safe, so it should not be used in MRI environments unless specifically confirmed by the manufacturer.