510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K012530Substantially Equivalent

Aa-1 System

Neurovision, Inc., Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012530 is the FDA 510(k) clearance record for AA-1 SYSTEM, a class I device, cleared for Neurovision, Inc. on under FDA product code HJT (Haploscope). FDA records list one 510(k) clearance for Neurovision, Inc. As of , FDA records show no recalls naming K012530.

Clearance record

Decision date
Received
(25 days to decision)
Product code
HJT Haploscope
Regulation
21 CFR 886.1340
Device class
Class I
Review panel
Ophthalmic
Applicant
Neurovision, Inc. 12300 Twinbrook Pkwy. Suite 230, Rockville MD
510(k) summary
Summary
Third party review
No

Clearances, product code HJT

Trailing 12 months

FDA records hold no clearances under product code HJT in the trailing twelve months.

FDA records show no clearances under product code HJT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HJT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260