FDA 510(k)

3D I-SCAN

K-Number: K974522 · 1998-02-25

Decision Date1998-02-25

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

3D 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 1998-02-25 under 510(k) number K974522. 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 3D I-SCAN?

3D I-SCAN is a medical device that received FDA 510(k) clearance on 1998-02-25. The listed applicant is Ophthalmic Technologies, Inc.. The 510(k) number is K974522.

When did 3D I-SCAN receive FDA 510(k) clearance?

3D I-SCAN received FDA 510(k) clearance on 1998-02-25, under 510(k) number K974522.

Who is the listed applicant for 3D 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 3D I-SCAN?

The FDA product code for 3D 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 K971679I-SCOPE OPHTHALMIC ENDOSCOPE

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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.