CR-1

K080883 · Canon, Inc. · HKI · Apr 24, 2008 · Ophthalmic

Device Facts

• Record ID: K080883
• Device Name: CR-1
• Applicant: Canon, Inc.
• Product Code: HKI · Ophthalmic
• Decision Date: Apr 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The device is intended to be used for taking digital images of retina of human eye without a mydriatic.

Device Story

Canon CR-1 is a digital ophthalmic camera designed for non-mydriatic retinal imaging. It integrates a Canon EOS digital camera to capture images, allowing for immediate viewing, telemedicine applications, and electronic filing. The device features an automatic chin rest, a digital magnification function for adjusting the angular field of view, and a 35 mm working distance. It is more compact and lighter than its predecessor, the CR-DGi. The device is used by clinicians to obtain retinal images, which are then reviewed to assist in clinical decision-making and patient documentation. The primary benefit is improved procedural efficiency in ophthalmic examinations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ophthalmic camera; digital imaging system; automatic chin rest; digital magnification function; 35 mm working distance; compact form factor. Optical components and mechanical structures are similar to the predicate CR-DGi.

Indications for Use

Indicated for capturing digital retinal images of human eyes without the use of a mydriatic agent.

Regulatory Classification

Identification

An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

Special Controls

*Classification.* Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Predicate Devices

• Canon CR-DGi (K031629)
• Canon CF-1 (K063717)

Submission Summary (Full Text)

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Section F: Summary

K080883

## Prepared:

#### Submitter:

Company Name: Company Address:

Contact Person: Phone Number: Fax Number:

#### Proposed Device:

Reason For 510(k): Manufacturer: Trade Name: Model Name: Classification Name: FDA 510(k) #:

### Predicate Device:

Manufacturer: Trade Name: Model Name: Classification Name: FDA 510(k) #:

Manufacturer: Trade Name: Model Name: Classification Name: FDA 510(k) #

Canon CF-1 86HKI. Ophthalmic cameras K063717

#### Description Of Device:

CR-1 is an improved model of CR-DGi.

Canon Inc.

Canon EOS Digital Camera is mounted with CR-1, can be viewed immediately, making procedures more efficient and many different applications, such as telemedicine and electronic filing.

CR-1's intended use is the same as that of CR-DGiand the CF-1 is only being used as a predicate device in regard to the chin rest motion.

The differences between CR-1 and CR-DGi are as follows; · The Chin Rest of CR-1 is moved automatically the same like CF-1. but for CR-DGi it is moved manually.

· CR-1 has digital magnification function to change angular field of view (24° (H) x 36° (W), diagonal angle of view: 43° ), while CR-DGi does not have such function.

· The Working distance (WD) of CR-1 is shorter than CR-DGi (CR-1: 35 mm, CR-DGi: 45 mm).

· CR-1 is visually more compact and lighter than CR-DGi.

CR-1 is equivalent to CR-DGi in the following respect:.

· The optical components and alignment and the mechanical structures of the CR-1 are almost same as the CR-DGi .

Intended Use: The device is intended to be used for taking digital images of retina of human eye without a mydriatic.

# 510(k) Summary

February 8, 2008

Canon USA, Inc. (U.S. agent for Canon Inc.) One Canon Plaza Lake Success, NY 11042 Ms. Sheila Driscoll [phone] [phone]

New Model Canon Inc. Canon CR-1 86HKI, Ophthalmic cameras To be assigned

Canon Inc. Canon CR-DGi 86HKI, Ophthalmic cameras K031629

APR 2 4 2008

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 2 4 2008

Conon, Inc. c/o Casey Conry Senior Projector Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Rd Melville, NY 11747

Re: K080883

Trade/Device Name: Canon Digital Retinal Camera CR-1 Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: April 17, 2008 Received: April 21, 2008

Dear Mr. Conry:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic roroduct radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Malvina B. Egerter, M.D.

Malvina B. Eydelman, M Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications Statement

| 510(K)Number(if known): | K080883 |
|-------------------------|------------------------------------------|
| Device Name: | CR-1 (Canon Digital Retinal Camera CR-1) |
| Indications for Use: | |

The device is intended to be used for taking digital images of retina of human eye without a mydriatic.

| Prescription Use | X | OR | Over-The-Counter Use |
|-----------------------------|---|----|-----------------------------|
| (Part 21 CFR 801 Subpart D) | | | (Part 21 CFR 801 Subpart C) |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERT PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

| | Page 1 of 1 |
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| (Division Sign-Off) | <img alt="Signature" src="signature.png"/> 4/23/2008 |
| Division of Ophthalmic Ear, Nose and Throat Devises | |
| 510(k) Number | K080883 |

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