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510(k) K973206

STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY by Sterling Diagnostic Imaging, Inc. — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1997
Date Received
August 26, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

Other clearances by Sterling Diagnostic Imaging, Inc.

  • K980970 — IIRAD DIRECTRAY OPERATOR CONSOLE (June 8, 1998)
  • K980220 — IISYS PACS SYSTEM (February 13, 1998)
  • K974423 — ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL (December 22, 1997)
  • K972660 — RAVEN DRY PRINTER (November 10, 1997)
  • K973028 — HELIOS LASER IMAGER 1417 (October 28, 1997)
  • K964250 — LINX NETWORKING SYSTEM (December 18, 1996)

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  • K243443 — EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXP (March 19, 2025)
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  • K243171 — Yushan X-Ray Flat Panel Detector (December 19, 2024)
  • K241319 — SKR 3000 (November 21, 2024)