Skip to content

Nova Ar 2.6.16

by Scopis GmbH

Nova Ar 2.6.16 (U4 003) is a Class II device made by Scopis GmbH, listed in FDA GUDID since 20 Feb 2018 (UDI-DI B057U4003260160), 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 NumberB057U4003260160 UDI-DI Date20 Feb 2018ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Nova Ar
Generic name
Stereotactic system application software
Model / Ref / Catalog
2.6.16, U4 003
Primary DI / UDI-DI
B057U4003260160
FDA product code
PGW
GMDN term
Stereotactic system application software
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Stereotactic system application software

Other devices from Scopis GmbH

See all devices from Scopis GmbH →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)