Camera, Ophthalmic, General-use
Ophthalmic · 21 CFR 886.1120
PJZ cameras are prescription devices indicated only for the capture and storage of images of the eye and surrounding area in the general population. PJZ cameras cannot be indicated for any specific population (e.g., pediatrics, AMD patients, etc.), cannot contain any type of diagnostic or aid in diagnosis claims in the indication for use, and cannot reference any specific disease. PJZ cameras do not exceed group 1 radiant exposure limits for ultraviolet, visible, and infrared radiation under all light energy conditions, as defined in the ANSI Z80.36-2016 standard Light Hazard Protection for Ophthalmic Instruments.
Recent MDR events
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
53 firms currently registered for this product code
Lombart Instrument, Inc. D/b/a Marco Ophthalmic
Jacksonville, FL, US
Phoenix Technology Group Llc
Pleasanton, CA, US
Retivue Llc
Charlottesville, VA, US
Frey Spolka Jawna
PIASECZNO Mazowieckie, PL
Oivi As
Oslo, NO
Forus Health Pvt.ltd.,
Bengaluru Karnataka, IN
Virtual Field, Inc
Brooklyn, NY, US
Chongqing Bio Newvision Medical Equipment Ltd.
Chongqing, CN
Cellview Imaging Inc.
Toronto Ontario, CA
Beijing Hongdee Corporation
Beijing, CN
Accutome, Inc.
Malvern, PA, US
Welch Allyn De Mexico, S. De R.l. De C.v.
TIJUANA Baja California, MX
Chongqing Sunkingdom Medical Instrument Co.,ltd
Chongqing, CN
Medimaging Integrated Solution Inc.
Hsinchu Hsinchu (City), TW
Rmf Design And Manufacturing Inc.
Mississauga Ontario, CA
Remidio Innovative Solutions Private Limited
Bengaluru Karnataka, IN
Shanghai Mediworks Precision Instruments Co., Ltd.
Shanghai, CN
Main Meditech Co., Ltd
Chongqing, CN
Shanghai Link Instruments Co.,ltd
Changzhou City Jiangsu, CN
Chongqing Kanghua Ruiming S&t Co., Ltd.
Chongqing, CN
Kys Vision, Inc.
Elko, NV, US
Identifeye Health Inc.
Redwood City, CA, US
Innokas Medical Estonia Ou
Tallinn Harjumaa, EE
Sr Research Ltd
Oakville Ontario, CA
Blephex, Llc
Brentwood, TN, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.