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PositView 567-11700-13

by Shimadzu Corporation

PositView 567-11700-13 is a Class II device made by Shimadzu Corporation, cleared under FDA 510(k) K240827 on 24 May 2024 and listed in FDA GUDID since 16 May 2025 (UDI-DI 04540217072798), active as of 12 Nov 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 12 Nov 2026

Documents

510(k) K240827

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04540217072798 UDI-DI Date16 May 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK240827 Date24 May 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K240827 decided 24 May 2024 Active
  • FDA GUDID UDI-DI 04540217072798 listed 16 May 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K240827
  2. Listed FDA GUDID 04540217072798

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
PositView
Generic name
PET system
Model / reference
567-11700-13
Primary DI / UDI-DI
04540217072798
510(k) Number
FDA product code
KPS
GMDN term
PET system
Device class
Class II
Regulation number
892.1200
GUDID distribution status
In Commercial Distribution

Related devices

Category: PET system

Cleared under the same submission (K240827)

Similar devices

Other devices filed under FDA product code KPS (System, Tomography, Computed, Emission).

Other devices from Shimadzu Corporation

See all devices from Shimadzu Corporation →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)