Skip to content

Sr-115-Cg

by Source-Ray, Inc.

Sr-115-Cg (900033) is a Class II device made by Source-Ray, Inc., cleared under FDA 510(k) K052001 on 11 Aug 2005 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00868162000234), active as of 1 Jun 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 1 Jun 2026

Documents

510(k) K052001

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 1 Jun 2026.

Regulatory status

as of registry sync 1 Jun 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00868162000234 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK052001 Date11 Aug 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K052001 decided 11 Aug 2005 Active
  • FDA GUDID UDI-DI 00868162000234 listed 9 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K052001
  2. Listed FDA GUDID 00868162000234

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Diagnostic x-ray system generator, mobile
Model / Ref / Catalog
SR-115, 900033
Primary DI / UDI-DI
00868162000234
510(k) Number
FDA product code
IZL
GMDN term
Diagnostic x-ray system generator, mobile
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.

  • Sb-60-333

    Class I
  • Sr-130-G

    Class II
  • Xrs-140-7.5K-P

    Class I
  • Rc-115

    Class II

See all devices from Source-Ray, Inc. →

Properties

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