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InsightRT Software Suite Server ISS100S

by Siris Medical

InsightRT Software Suite Server ISS100S, a radiation therapy software (FDA Class II; FDA product code MUJ, System,Planning,Radiation Therapy Treatment) made by Siris Medical, was cleared under FDA 510(k) K151560 on 11 Sep 2015 and listed in FDA GUDID on 8 Aug 2016 (UDI-DI B244ISS100S0); the registry lists it as not in commercial distribution (GUDID) as of 23 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 23 Oct 2026

Documents

510(k) K151560

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB244ISS100S0 UDI-DI Date8 Aug 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK151560 Date11 Sep 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151560 decided 11 Sep 2015 Active
  • FDA GUDID UDI-DI B244ISS100S0 listed 8 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K151560
  2. Listed FDA GUDID B244ISS100S0

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
InsightRT Software Suite Server
Generic name
Radiation therapy software
Model / Ref / Catalog
ISS100S
Primary DI / UDI-DI
B244ISS100S0
510(k) Number
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

Cleared under the same submission (K151560)

Similar devices

Other devices filed under FDA product code MUJ (System,Planning,Radiation Therapy Treatment).

Other devices from Siris Medical

  • InsightRT CDS IRT100

    Class II

  • QuickPlan

    Class II

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (13, all answered No)