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510(k) K964137

RTA RETINAL THICKNESS ANALYZER by Talia Technology , Ltd. — Product Code HLI

K964137 is an FDA 510(k) premarket notification submitted by Talia Technology , Ltd. for the device "RTA RETINAL THICKNESS ANALYZER". The FDA issued a decision of Substantially Equivalent on February 3, 1997. The device falls under product code HLI (Ophthalmoscope, Ac-Powered), a Class II device regulated under 21 CFR 886.1570. Talia Technology , Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1997
Date Received
October 15, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Ac-Powered
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

Other clearances by Talia Technology , Ltd.

  • K061674 — RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER (August 23, 2006)
  • K041290 — RTA MODEL D RETINAL THICKNESS ANALYZER (May 24, 2004)
  • K031312 — RTA MODEL D RETINAL THICKNESS ANALYZER (May 6, 2003)
  • K000731 — MODIFICATION TO RTA RETINAL THICKNESS ANALYZER (March 31, 2000)
  • K930518 — TALIA LASER SLIT (January 25, 1994)

Other clearances for product code HLI

  • K153080 — RTVue XR OCT Avanti with AngioVue Software (February 11, 2016)
  • K150722 — EnFocus 2300, EnFocus 4400 (December 2, 2015)
  • K142953 — OCT-Camera (March 4, 2015)
  • K141638 — PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE (September 17, 2014)
  • K133758 — CENTERVUE MACULAR INTEGRITY ASSESSMENT (April 23, 2014)
  • K131939 — AMICO DH-W35 OPHTHALMOSCOPE SERIES (March 26, 2014)
  • K133892 — IVUE 500 (March 19, 2014)
  • K123316 — HEINE OMEGA 500 (February 26, 2013)
  • K121739 — IVUE WITH NORMATIVE DATABASE (January 18, 2013)
  • K120057 — ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) (May 11, 2012)

FDA data resources