FDA 510(k)

I-SCAN

K-Number: K960622 · 1996-05-13

Decision Date1996-05-13

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

I-SCAN is the device name listed in this FDA 510(k) record. The listed applicant is Ophthalmic Technologies, Inc.. It received FDA 510(k) clearance on 1996-05-13 under 510(k) number K960622. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-SCAN?

I-SCAN is a medical device that received FDA 510(k) clearance on 1996-05-13. The listed applicant is Ophthalmic Technologies, Inc.. The 510(k) number is K960622.

When did I-SCAN receive FDA 510(k) clearance?

I-SCAN received FDA 510(k) clearance on 1996-05-13, under 510(k) number K960622.

Who is the listed applicant for I-SCAN?

The FDA 510(k) record lists Ophthalmic Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I-SCAN?

The FDA product code for I-SCAN is IYO.

Other records listing Ophthalmic Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K042885OCT-OPTHALMOSCOPE K031391HF MODULE WITH TRANSDUCERS K030770OTI SCAN WITH TRANSDUCERS K024114A-SCAN 100 K990064DI-RHEX OPHTHALMIC DIATHERMY SYSTEM K9745223D I-SCAN

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.