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Raypilot Receiver 1

by Micropos Medical AB (Publ)

Raypilot Receiver 1 (2020) is a medical device (FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by Micropos Medical AB (Publ), cleared under FDA 510(k) K203722 on 2 Sep 2021 and listed in FDA GUDID since 12 Mar 2025 (UDI-DI 07350007952202), 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) K203722

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 Number07350007952202 UDI-DI Date12 Mar 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK203722 Date2 Sep 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K203722 decided 2 Sep 2021 Active
  • FDA GUDID UDI-DI 07350007952202 listed 12 Mar 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K203722
  2. Listed FDA GUDID 07350007952202

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Raypilot Receiver
Generic name
Radiation therapy invasive marker lesion localization system
Model / Ref / Catalog
1, 2020
Primary DI / UDI-DI
07350007952202
510(k) Number
FDA product code
IYE
GMDN term
Radiation therapy invasive marker lesion localization system
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code IYE (Accelerator, Linear, Medical).

Other devices from Micropos Medical AB (Publ)

See all devices from Micropos Medical AB (Publ) →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)