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The Spantron Frame Freeze

by Spantron, Inc.

510(k) K890477

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK890477 Date31 Mar 1989ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
LMA
Device Class
Class II
Regulation
21 CFR Part 892.2030
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Spantron Frame Freeze is a Class II medical device used in radiology. It is an image digitizer that captures and processes radiological images.

The device is supplied by Spantron, Inc. and has FDA 510(k) clearance with product code LMA. It is used in radiology settings and has multiple model numbers including K890477.

Other devices from Spantron, Inc.

Questions

AI-generated answers, 24 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 clinical function does the Spantron Frame Freeze perform?

    It digitizes radiological images, converting analog outputs from imaging equipment into digital files that can be stored, viewed, and transmitted within a radiology workflow. This enables faster image review and integration with picture‑archiving systems.

  • Is the Spantron Frame Freeze supplied as a single unit or in multiple configurations?

    The device is supplied by Spantron, Inc. as a single, self‑contained unit. Different model numbers, such as K890477, identify the specific configuration, but each model is delivered ready for installation without additional components.

  • What regulatory pathway was used for the Spantron Frame Freeze?

    The device received traditional FDA 510(k) clearance, indicating it was found substantially equivalent to a legally marketed predicate device. This clearance is recorded under product code LMA.

  • How should the Spantron Frame Freeze be stored before use?

    The device should be stored in a standard clinical environment at the manufacturer’s address (Suite 373, 3380 Sheridan Dr., Amherst, NY 14226). No special temperature or humidity controls are specified, so routine office conditions are appropriate.