Home / 510(k) Clearances / K120752

510(k) K120752

AERODR STITCHING SYSTEM by Konica Minolta Medical & Graphic, Inc. — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2012
Date Received
March 12, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

Other clearances by Konica Minolta Medical & Graphic, Inc.

  • K130936 — AERODR SYSTEM WITH P-31 (August 22, 2013)
  • K123499 — AEROPILOT (December 20, 2012)
  • K121109 — AERODR X70 (May 23, 2012)
  • K120477 — AEROSYNC FOR AERODR SYSTEM (April 9, 2012)
  • K120131 — REGIUS SIGMA2 (February 10, 2012)
  • K113248 — AERODR SYSTEM WITH P-21 (January 17, 2012)
  • K110717 — KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM (December 23, 2011)
  • K103703 — REGUIS SIGMA (June 2, 2011)
  • K101842 — ACIES (February 4, 2011)
  • K102349 — AERODR SYSTEM (November 24, 2010)

Other clearances for product code KPR

  • K250954 — DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 dete (January 20, 2026)
  • K252000 — uDR Arria & uDR Aris (November 26, 2025)
  • K251167 — uDR Aurora CX (September 19, 2025)
  • K250788 — Definium Tempo Select (August 28, 2025)
  • K250790 — INNOVISION-DXII (August 1, 2025)
  • K250738 — YSIO X.pree (July 31, 2025)
  • K242019 — GXR-Series Diagnostic X-Ray System (January 7, 2025)
  • K242499 — Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) (January 6, 2025)
  • K242119 — INNOVISION-EXII (January 3, 2025)
  • K241068 — uDR 780i (November 1, 2024)