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TLP260

by Phantom Laboratory

Ref TLP260510(k) K081760

TLP260 is a medical device (EU MDD Class I; FDA Class II; FDA product code IYE; EMDN category various bioimaging and radiotherapy instruments - hardware accessories) made by Phantom Laboratory, registered in EUDAMED on 23 Feb 2023 (Basic UDI-DI B-TLP260HX) and cleared under FDA 510(k) K081760 on 29 Jul 2008, active as of 24 Oct 2026.

Active European Union and United States

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K081760↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-TLP260HX Basic UDI-DI D-TLP260HXUDI-DIDate23 Feb 2023RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK081760 Date29 Jul 2008ClearedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-TLP260HX registered 23 Feb 2023 Active
  • FDA 510(k) K081760 decided 29 Jul 2008 Active

Timeline

2 dated events

  1. Cleared FDA 510(k) K081760
  2. Registered EUDAMED B-TLP260HX

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDD Active

Specification

EUDAMED · 510(k)

Device name
TLP260
Model / reference
TLP260
Primary DI / UDI-DI
D-TLP260HX
Basic UDI-DI
B-TLP260HX
510(k) Number
FDA product code
IYE
EMDN code
Z119080 Various bioimaging and radiotherapy instruments - hardware accessories
Device class
Class I EUDAMED
Class II 510(k)
Regulation
21 CFR Part 892.5050
EU registration type
Legacy device (under a directive)
EU market of registration
Sweden
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device classEUDAMED
Class I
510(k)
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA 510(k)). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Manufacturer details

EUDAMED SRN
US-MF-000027490
Authorised representative
Hoff & Lowendahl AB SE-AR-000001888

Similar devices in this category

Other devices filed under VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Phantom Laboratory

See all devices from Phantom Laboratory →

Properties

Other properties (12, all answered No)