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510(k) K013291

ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) by Advanced Diagnostics, Inc. — Product Code NCS

K013291 is an FDA 510(k) premarket notification submitted by Advanced Diagnostics, Inc. for the device "ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)". The FDA issued a decision of Substantially Equivalent on November 14, 2001. 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 14, 2001
Date Received
October 2, 2001
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)
  • K001510 — OS-2000 OPTICAL SONOGRAPHY SYSTEM (November 30, 2000)

Other clearances for product code NCS

  • K013886 — AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) (May 10, 2002)
  • K001510 — OS-2000 OPTICAL SONOGRAPHY SYSTEM (November 30, 2000)

FDA data resources