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Oncospace System

by Oncospace, Inc.

Oncospace System is a Class II device made by Oncospace, Inc., cleared under FDA 510(k) K202284 on 12 Mar 2021 and listed in FDA GUDID since 8 Jun 2021 (UDI-DI 00860004284901), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K202284

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860004284901 UDI-DI Date8 Jun 2021ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK202284 Date12 Mar 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K202284 decided 12 Mar 2021 Active
  • FDA GUDID UDI-DI 00860004284901 listed 8 Jun 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K202284
  2. Listed FDA GUDID 00860004284901

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Oncospace
Generic name
Radiation therapy software
Model / reference
System
Primary DI / UDI-DI
00860004284901
FDA product code
MUJ
GMDN term
Radiation therapy software
Device class
Class II
Regulation number
892.5050
GUDID distribution status
Not in Commercial Distribution

Related devices

Category: Radiation therapy software

Similar devices in this category

Other devices filed under Radiation therapy software.

Other devices from Oncospace, Inc.

  • Oncospace

    Class II

  • Oncospace

    Class II

  • Oncospace

    Class II

Properties

  • Prescription use
Other properties (14, all answered No)