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Rc-115

by Source-Ray, Inc.

Rc-115 (900035) is a Class II device made by Source-Ray, Inc., cleared under FDA 510(k) K062472 on 31 Oct 2006 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00868162000289), active as of 21 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 21 Oct 2026

Documents

510(k) K062472

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00868162000289 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK062472 Date31 Oct 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K062472 decided 31 Oct 2006 Active
  • FDA GUDID UDI-DI 00868162000289 listed 9 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K062472
  2. Listed FDA GUDID 00868162000289

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Diagnostic radiography device remote control
Model / Ref / Catalog
RC-115, 900035
Primary DI / UDI-DI
00868162000289
510(k) Number
FDA product code
IZL
GMDN term
Diagnostic radiography device remote control
Device class
Class II
Regulation number
892.1720
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code IZL (System, X-Ray, Mobile).

Other devices from Source-Ray, Inc.

  • Sr-115-Cg

    Class II
  • Sb-60-333

    Class I
  • Sr-130-G

    Class II
  • Xrs-140-7.5K-P

    Class I

See all devices from Source-Ray, Inc. →

Properties

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