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Delta4 Phantom+ PW

by Scandidos AB

Delta4 Phantom+ PW (SDOS101-21) is a multi-modality therapeutic radiation phantom (FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by Scandidos AB, listed in FDA GUDID since 25 Sep 2016 (UDI-DI 17350005180017), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number17350005180017 UDI-DI Date25 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Delta4 Phantom+
Generic name
Multi-modality therapeutic radiation phantom, anthropomorphic
Model / Ref / Catalog
PW, SDOS101-21
Primary DI / UDI-DI
17350005180017
FDA product code
IYE
GMDN term
Multi-modality therapeutic radiation phantom, anthropomorphic
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Multi-modality therapeutic radiation phantom, anthropomorphic

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Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)