Cleared Traditional

K974535 - DISCAM DIGITAL IMAGING SYSTEM

K974535 is an FDA 510(k) clearance for DISCAM DIGITAL IMAGING SYSTEM, manufactured by Marcher Enterprises, Ltd.. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K974535 · Marcher Enterprises, Ltd. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
255d
Days
Class 2
Risk

K974535 is an FDA 510(k) clearance for the DISCAM DIGITAL IMAGING SYSTEM. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Marcher Enterprises, Ltd. (Hereford, Herefordshire, GB). The FDA issued a Cleared decision on August 14, 1998 after a review of 255 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1120 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K974535

510(k) Number K974535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1997
Decision Date August 14, 1998
Days to Decision 255 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 110d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HKI Device Classification - Class 2, Special Controls

Product Code HKI Camera, Ophthalmic, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HKI Camera, Ophthalmic, Ac-powered

All 153
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K974535.
EYECAP IMAGING SYSTEM
K000368 · Clement Clarke Intl., Ltd. · May 2000
DIGISCOPE OPHTHALMIC CAMERA
K990205 · Eye Tel Imaging, Inc. · Mar 1999
WINSTATION RETINAL IMAGER
K982689 · Ophthalmic Imaging Systems · Oct 1998
OPHTHAVISION IMAGING SYSTEM
K980295 · Mrp Group, Inc. · May 1998
NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM
K980246 · Canon USA, Inc. · May 1998
KONAN NONCON ROBO PACHY SPECULAR MICROSCOPE AND OPTICL PACHYMETER
K980357 · Konan, Inc. · Apr 1998
K974535 · DISCAM DIGITAL IMAGING SYSTEM
Download PDF FDA Summary Marcher Enterprises, …