Cleared Traditional

K201273 - ImageSPECTRUM

K201273 is an FDA 510(k) clearance for ImageSPECTRUM, manufactured by Canon, Inc.. The device is a Class 2 Ophthalmic device with product code NFJ cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K201273 · Canon, Inc. · Ophthalmic device
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Sep 2020
Decision
136d
Days
Class 2
Risk

K201273 is an FDA 510(k) clearance for the ImageSPECTRUM. Classified as System, Image Management, Ophthalmic (product code NFJ), Class II - Special Controls.

Submitted by Canon, Inc. (Nakahara-Ku, Kawasaki, JP). The FDA issued a Cleared decision on September 25, 2020 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 892.2050 - 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.

View all Canon, Inc. devices

FDA 510(k) Submission Details - K201273

510(k) Number K201273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2020
Decision Date September 25, 2020
Days to Decision 136 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
26d slower than avg
Panel avg: 110d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NFJ Device Classification - Class 2, Special Controls

Product Code NFJ System, Image Management, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - NFJ System, Image Management, Ophthalmic

All 47
Devices cleared under the same product code (NFJ) and FDA review panel - the closest regulatory comparables to K201273.
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