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510(k) K012080

SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM by Aloka Co., Ltd. — Product Code IYN

K012080 is an FDA 510(k) premarket notification submitted by Aloka Co., Ltd. for the device "SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM". The FDA issued a decision of Substantially Equivalent on August 29, 2001. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Aloka Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2001
Date Received
July 3, 2001
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

Other clearances by Aloka Co., Ltd.

  • K111227 — ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM (May 13, 2011)
  • K110207 — ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM (February 17, 2011)
  • K093488 — ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM (November 20, 2009)
  • K083254 — ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM (December 19, 2008)
  • K081843 — ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1 (July 15, 2008)
  • K080176 — ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM (February 29, 2008)
  • K072285 — ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM (August 30, 2007)
  • K060059 — ALOKA SD-3500 ULTRASOUND SYSTEM (January 13, 2006)
  • K043196 — ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM (November 30, 2004)
  • K040719 — ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM (March 26, 2004)

Other clearances for product code IYN

  • K261313 — Vivid Explorer/Vivid Advanced/Vivid Focus (September 2, 2026)
  • K254027 — Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo (August 24, 2026)
  • K261668 — Venue Go (August 7, 2026)
  • K262311 — Alturion Series Diagnostic Ultrasound System (August 4, 2026)
  • K261288 — Handheld Ultrasound Scanner (July 30, 2026)
  • K261835 — LOGIQ Focus (July 30, 2026)
  • K261412 — V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound Sy (July 28, 2026)
  • K261211 — Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagno (July 27, 2026)
  • K261081 — Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) (July 23, 2026)
  • K261272 — ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePa (July 23, 2026)

FDA data resources