(24 days)
No
The description focuses on hardware improvements and digital imaging capabilities, with no mention of AI or ML for image analysis or other functions.
No
The device is described as taking digital images of the retina and its intended use is for imaging, not for treating or preventing a condition.
No
The device is described as taking digital images of the retina but does not mention any diagnostic capabilities or an intended use for diagnosing conditions.
No
The device description clearly details hardware components like a Canon EOS Digital Camera, optical components, mechanical structures, and a chin rest, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for taking digital images of retina of human eye without a mydriatic." This describes a device used for imaging the eye, not for performing tests on biological samples (like blood, urine, or tissue) to diagnose diseases or conditions.
- Device Description: The description focuses on the physical characteristics and functionality related to capturing images of the retina. It mentions optical components, mechanical structures, and features like digital magnification and working distance. These are all consistent with an imaging device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any process that would involve testing in vitro.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (within the body) by capturing images of the retina.
N/A
Intended Use / Indications for Use
The device is intended to be used for taking digital images of retina of human eye without a mydriatic.
Product codes
86HKI
Device Description
CR-1 is an improved model of CR-DGi.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital images
Anatomical Site
retina of human eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
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.
0
Section F: Summary
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 (516) 328-5602 (516) 328-5169
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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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in promoting health and well-being in the United States.
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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 | |
|---|---|
| (Division Sign-Off) | 4/23/2008 |
| Division of Ophthalmic Ear, Nose and Throat Devises | |
| 510(k) Number | K080883 |
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