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510(k) K001510

OS-2000 OPTICAL SONOGRAPHY SYSTEM by Advanced Diagnostics, Inc. — Product Code NCS

K001510 is an FDA 510(k) premarket notification submitted by Advanced Diagnostics, Inc. for the device "OS-2000 OPTICAL SONOGRAPHY SYSTEM". The FDA issued a decision of Substantially Equivalent on November 30, 2000. The device falls under product code NCS (System, Imaging, Holography, Acoustic), a Class II device regulated under 21 CFR 892.1550. Advanced Diagnostics, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2000
Date Received
May 15, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Holography, Acoustic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

Other clearances by Advanced Diagnostics, Inc.

  • K023037 — MID STREAM PREGNANCY TEST (April 9, 2003)
  • K013886 — AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) (May 10, 2002)
  • K013291 — ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) (November 14, 2001)

Other clearances for product code NCS

  • K013886 — AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) (May 10, 2002)
  • K013291 — ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) (November 14, 2001)

FDA data resources