(30 days)
Not Found
No
The summary describes a digital retinal camera and its basic functionality, but there is no mention of AI, ML, or any advanced image processing that would suggest the use of such technologies.
No
The device is described as taking digital images of the retina and does not mention any therapeutic capabilities or interventions. Its function is solely for imaging and documentation.
No
The device is described as taking digital images of the retina, which is an imaging function, not a diagnostic one. There is no mention of analysis, interpretation, or detection of disease.
No
The device description explicitly states it is a "DIGITAL RETINAL CAMERA CR-1 Mark II" and that a "Canon EOS Digital Camera is mounted to the CR-1 Mark II." This indicates the device includes significant hardware components (the camera and the CR-1 Mark II unit) in addition to any potential software for image viewing or processing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is used for "taking digital images of retina of human eye." This is an in vivo (within the living body) imaging procedure, not an in vitro (outside the living body) diagnostic test.
- Intended Use: The intended use is to capture images of the retina, not to analyze biological samples for diagnostic purposes.
Therefore, the DIGITAL RETINAL CAMERA CR-1 Mark II is a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The device's intended use is for taking digital images of a human retina without a mydriatic.
The device is intended to be used for taking digital images of retina of human eye without a mydriatic.
Product codes (comma separated list FDA assigned to the subject device)
HKI
Device Description
The DIGITAL RETINAL CAMERA CR-1 Mark II is used for taking digital images of a human retina without a mydriatic. Canon EOS Digital Camera is mounted to the CR-1 Mark II. Images can be viewed immediately, making procedures more efficient with many different applications, such as telemedicine and electronic filing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human retina, 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows a handwritten text string "K09 0Y66" enclosed in an oval shape. The characters are written in a cursive style, with some variations in stroke thickness. The oval shape appears to be hand-drawn as well, with slight irregularities in its outline.
510(k) Summary
Prepared:
December 10. 2008
MAR 2 3 2009
Submitter:
Company Name: Company Address:
Contact Person: Phone Number: Fax Number:
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
Proposed Device:
| Reason For 510(k): |
|---|
| Manufacturer: |
| Trade Name: |
| Model Name: |
| Classification Name: |
| FDA 510(k) #: |
New Model Canon Inc. Canon CR-1 Mark II 86HKI, ophthalmic cameras To be assigned
Predicate Device:
Manufacturer: Trade Name: Model Name: Classification Name: FDA 510(k) #:
Canon Inc. Canon CR-1 86HKI. ophthalmic cameras K080883
Description of Device: The DIGITAL RETINAL CAMERA CR-1 Mark II is used for taking digital images of a human retina without a mydriatic. Canon EOS Digital Camera is mounted to the CR-1 Mark II. Images can be viewed immediately, making procedures more efficient with many different applications, such as telemedicine and electronic filing.
| The differences between CR-1 and CR-1 Mark II are as follows; | ||||
|---|---|---|---|---|
| CR-1 | CR-1 Mark II | |||
| Flash intensity | Standard mode | 1 | 1/2 | |
| Low flash intensity | ||||
| mode(LOW1) | 1/2 | 1/4 | ||
| Low flash intensity | ||||
| mode(LOW2) | 1/8 |
1 CD 4 M-14 U ﻋﺘﺮﺍﻧ
*In comparison with CR-1 standard mode.
Intended Use: The device's intended use is for taking digital images of a human retina without a mydriatic.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are written around the eagle in a circular pattern. The eagle is facing to the right and has three legs.
Public Health Service
MAR 2 3 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD. 20850
Canon, Inc. c/o Casey Conry Underwriters Laboratories, Inc. 1285 Walt Whitman Rd. Melville, NY 11747
K090466 Re: Trade/Device Name: DIGITAL RETINAL CAMERA CR-1 MARK II Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: Class II Product Code: HKI Dated: March 13, 2009 Received: March 17, 2009
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 for association 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 Crici in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
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,
M.B. Egleston, m.d.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications Statement
510(K)Number(if known):
Kogo466
Device Name: CR-1 Mark II
Indications for Use:
The device is intended to be used for taking digital images of retina of human eye without a mydriatic.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE…CONTINUE ON ANOTHERT PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation(ODE)
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(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices
510(k) Number K090466