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Elk Laser Film Digitizer

by Nishimoto Sangyo Co., Ltd. 510(k)

Active United States

510(k) K984409

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK984409 Date12 Feb 1999ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 10 Oct 2026.

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

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