510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K952480Substantially Equivalent

Orims Digital Angiography System

Midwest Ophthalmic Instruments, Inc., Romeoville IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952480 is the FDA 510(k) clearance record for ORIMS DIGITAL ANGIOGRAPHY SYSTEM, a class II device, cleared for Midwest Ophthalmic Instruments, Inc. on under FDA product code HKI (Camera, Ophthalmic, Ac-Powered). FDA records list one 510(k) clearance for Midwest Ophthalmic Instruments, Inc. As of , FDA records show no recalls naming K952480.

Clearance record

Decision date
Received
(87 days to decision)
Product code
HKI Camera, Ophthalmic, Ac-Powered
Regulation
21 CFR 886.1120
Device class
Class II
Review panel
Ophthalmic
Applicant
Midwest Ophthalmic Instruments, Inc. 1237 Naperville Dr., Romeoville IL
510(k) summary
Statement
Third party review
No

Clearances, product code HKI

Trailing 12 months
3 clearances under product code HKI in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HKI, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260