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Esteya 187115-03

by Nucletron B.V.

Esteya 187115-03 is a skin-tumour low-voltage therapeutic x-ray system (FDA Class II; FDA product code JAD, System, therapeutic, x-ray) made by Nucletron B.V., cleared under FDA 510(k) K132092 on 26 Sep 2013 and listed in FDA GUDID since 10 Sep 2016 (UDI-DI 08717213036161), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

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) K132092

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 Number08717213036161 UDI-DI Date10 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK132092 Date26 Sep 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K132092 decided 26 Sep 2013 Active
  • FDA GUDID UDI-DI 08717213036161 listed 10 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K132092
  2. Listed FDA GUDID 08717213036161

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Esteya
Generic name
Skin-tumour low-voltage therapeutic x-ray system
Model / reference
187115-03
Primary DI / UDI-DI
08717213036161
510(k) Number
FDA product code
JAD
GMDN term
Skin-tumour low-voltage therapeutic x-ray system
Device class
Class II
Regulation number
892.5900
GUDID distribution status
In Commercial Distribution

Related devices

Category: Skin-tumour low-voltage therapeutic x-ray system

Cleared under the same submission (K132092)

and 8 more cleared under K132092

Similar devices

Other devices filed under FDA product code JAD (System, therapeutic, x-ray).

Other devices from Nucletron B.V.

See all devices from Nucletron B.V. →

Properties

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