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
K210197Substantially Equivalent

NFC-600 Automated Portable Retinal Camera

Crystalvue Medical Corporation, Taoyuan City, TW / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210197 is the FDA 510(k) clearance record for NFC-600 Automated Portable Retinal Camera, a class II device, cleared for Crystalvue Medical Corporation on under FDA product code HKI (Camera, Ophthalmic, Ac-Powered). FDA records list 3 510(k) clearances for Crystalvue Medical Corporation, from to . As of , FDA records show no recalls naming K210197.

Clearance record

Decision date
Received
(78 days to decision)
Product code
HKI Camera, Ophthalmic, Ac-Powered
Regulation
21 CFR 886.1120
Device class
Class II
Review panel
Ophthalmic
Applicant
Crystalvue Medical Corporation # 116, Ln.956, Zhongshan Rd., Taoyuan Dist.,, Taoyuan City, TW
510(k) summary
Summary PDF
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