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Accusoft

by Direx Systems Corp. 2 variants

510(k) K032171

Accusoft is a medical device (FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by Direx Systems Corp., cleared under FDA 510(k) K032171 on 15 Dec 2003, active as of 22 Oct 2026.

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK032171 Date15 Dec 2003ClearedStatusActive

Official records

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  • Withdrawn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
IYE
Device class
Class II
Regulation
21 CFR Part 892.5050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Similar devices

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

Other devices from Direx Systems Corp.

See all devices from Direx Systems Corp. →