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AeroDR 0170CS AACW

by Konica Minolta, Inc.

AeroDR 0170CS AACW is a Class II device made by Konica Minolta, Inc., cleared under FDA 510(k) K121109 on 23 May 2012 and listed in FDA GUDID since 26 Jul 2018 (UDI-DI 04560141946262), 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) K121109

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 Number04560141946262 UDI-DI Date26 Jul 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK121109 Date23 May 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K121109 decided 23 May 2012 Active
  • FDA GUDID UDI-DI 04560141946262 listed 26 Jul 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K121109
  2. Listed FDA GUDID 04560141946262

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AeroDR 0170CS
Generic name
X-ray system tube support, ceiling mounted
Model / reference
AACW
Primary DI / UDI-DI
04560141946262
510(k) Number
FDA product code
KPR
GMDN term
X-ray system tube support, ceiling mounted
Device class
Class II
Regulation number
892.1680
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Similar devices

Other devices filed under FDA product code KPR (System, X-Ray, Stationary).

Other devices from Konica Minolta, Inc.

See all devices from Konica Minolta, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)