(14 days)
Not Found
No
The summary describes a digital fundus camera for taking images of the retina and mentions immediate viewing and applications like telemedicine and electronic filing. There is no mention of AI, ML, or any advanced image processing beyond basic digital capture and viewing.
No
The device is described as taking digital images of the retina, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.
No
The intended use states that the device is for taking digital images of the retina, which is an imaging function, not a diagnostic one. There is no mention of analysis, interpretation, or diagnosis of retinal conditions.
No
The device description explicitly states it is a "DIGITAL FUNDUS CAMERA" and mentions a "Canon EOS Digital Camera is mounted with CF-60DSi," indicating it is a hardware device with integrated software, not a standalone software-only device.
Based on the provided information, the DIGITAL FUNDUS CAMERA CF-60DSi is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The CF-60DSi is a camera used to take images of the retina within the human eye. It does not analyze samples taken from the body.
- Intended Use: The intended use is to take digital images of the retina, which is a direct imaging procedure, not an in vitro test.
Therefore, the CF-60DSi falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
DIGITAL FUNDUS CAMERA CF-60DSi is intended to be used for taking digital images of retina of human eye with a mydriatic.
Product codes (comma separated list FDA assigned to the subject device)
HKI
Device Description
CF-60DSi is an improved model of CF-60UVi. The DIGITAL FUNDUS Doorfpack CF-60DSi is used for taking digital images of retina of human eye without a mydriatic. Canon EOS Digital Camera is mounted with CF-60DSi, can be viewed immediately, making oundly 200 Digitiont and 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
retina of human eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Ophthalmologist
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 G: Summary
510(k) Summary
Prepared:
March 31, 2004
Submitter:
| Company Name: | Canon USA, Inc. (U.S. agent for Canon Inc.) |
|---|---|
| Company Address: | One Canon Plaza |
| Lake Success, NY 11042 | |
| Contact Person: | Ms. Sheila Driscoll |
| Phone Number: | (516) 328-5602 |
| Fax Number: | (516) 328-5169 |
Proposed Device:
| Reason For 510(k): | New Model |
|---|---|
| Manufacturer: | Canon Inc. |
| Trade Name: | Canon |
| Model Name: | CF-60DSi |
| Classification Name: | 86HKI, Ophthalmic cameras |
| FDA 510(k) #: | To be assigned |
Predicate Device:
| Manufacturer: | Canon Inc. |
|---|---|
| Trade Name: | Canon |
| Model Name: | CF-60UVi |
| Classification Name: | 86HKI, Ophthalmic cameras |
| FDA 510(k) #: | K946058 |
CF-60DSi is intended to be used for taking digital images pictures of retina Intended Use: of human eye with a mydriatic.
Description Of Device: CF-60DSi is an improved model of CF-60UVi. The DIGITAL FUNDUS Doorfpack CF-60DSi is used for taking digital images of retina of human eye without a mydriatic. Canon EOS Digital Camera is mounted with CF-60DSi, can be viewed immediately, making oundly 200 Digitiont and many different applications, such as telemedicine and electronic filing.
The CF-60DSi's intended use is the same as that of CF-60UVi. However, the differences in design are as follows:
- EOS digital camera can be attached to the main unit of CF-60DSi directly. But CF-60UVi . cannot be attached without an adapter.
- cannot of attached while at and mount of CF-60DSi with the adapter. The . 100 angliar cambera can be attached to the sub mount of CF-60UVi with the adapter, and 35mm camera can be attached with the 35mm double adapter, and also Polaroid film unit can be attached without the adapter.
- While CF-60DSi has 2 variable powers (60/40 degree), CF-60UVi has 3 variable powers (60/40/30 degree).
- A data card cannot be used. •
1
Section G: Summary
CF-60DSi is equivalent to CF-60UVi in the following respect:
- The optical components and alignment. .
- The optical components and allgament.
The mechanical structures of the CF-60DSi are almost same as the CF-60UVi. Please refer to . the CF-60DSi comparison table provided in this section.
| Table of comparison | ||||
|---|---|---|---|---|
| CF-60UVi | CF-60DSi | |||
| PERFORMANCE | Angle of view | 60/40/30° | 60/40° | |
| Actual image size | $$\phi$ 29×22(on 35mm film) | Same(on monitor) | ||
| $$\phi$ 7.5×5.7(Type 1:on sensor array) | Same | |||
| $$\phi$ 4.9×3.7(Type 2:on sensor array) | No Applicable | |||
| $$\phi$ 75×57(on Polaroid film) | No Applicable | |||
| Min. diameter of pupil | ||||
| required | $$\phi$ 5.5mm(60/40/30°) | Same(60/40°) | ||
| $$\phi$ 4.0mm(with S.P switch ON in 30°) | $$\phi$ 4.0mm(with S.P switch ON in 40°) | |||
| Working distance(WD) | 45mm | Same | ||
| Focusing | By aligning the split lines | Same | ||
| Data to be printed | Hand-written data | No Applicable | ||
| Eye fixation lamp | External | Same | ||
| Filter set | Automatic/Manual | Same | ||
| Light source for | ||||
| photography | Max. 300WS | Same | ||
| Image unit | EOS Digital Camera(with Adapter) | EOS Digital Camera | ||
| CCD camera(with Adapter) | No Applicable | |||
| 3CCD camera(with Adapter) | No Applicable | |||
| 35mm film unit | No Applicable | |||
| Polaroid film unit | No Applicable | |||
| No Applicable | ICG digital camera(with Adapter) | |||
| Working range | ||||
| Vertical | ||||
| Forward and back | ||||
| Right and left | ||||
| Chin rest (vertically) | 38mm | Same | ||
| 70mm | Same | |||
| 120mm | Same | |||
| 65mm | Same | |||
| Panning | 30° right or left | Same | ||
| External dimensions | ||||
| Main unit | W320×D560×H565mm | Same | ||
| Power control unit | W225×D390×H520mm | W225×D380×H485mm | ||
| Weight | ||||
| Main unit | Approx.26kg | Approx.27kg | ||
| Power control unit | Approx.30kg | Approx.27kg | ||
| Intended use | Taking picture of retina of human eye | Same | ||
| Energy | ||||
| used | 1000VA | Same | ||
| delivered | No Applicable | Same | ||
| Target population | Ophthalmologist | Same | ||
| Physical safety | UL544 | UL60601-1 | ||
| Compliance with standards | UL544 | UL60601-1 | ||
| Biocompatibility | No Applicable | Same | ||
| Labeling | ||||
| Packaging | Printed model name is changed |
Table of comparison
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 2004
Canon, Inc. c/o Glenn M. Luchen Underwriters Laboratories, Inc. 1285 Walt Whitman Rd. Melville, NY 11747
K041546 Re:
K041540
Trade/Device Name: Digital Fundus Camera, Model CF-60DSi Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: Class II Product Code: HKI Dated: June 7, 2004 Received: June 9, 2004
Dear Mr. Luchen:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section JTV(K) premainer in substantially equivalent (for the indications
referenced above and have determined the device is substantial in interstate ferenced above and nave determined the arrest and devices marketed in interstate for use stated in the encrosule, to regally mancess promotical Device Amendments, or to commerce prior to May 20, 1970, the characted with the provisions of the Federal Food. Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previous of the Act . The and Cosment Act (Act) that to not require approval controls provisions of the Act. The You may, merelore, market the device, subject to the gents for annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the frectines and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (Scc above) inl. - Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation E may be subject to such additional controls: Extrems - 1998 In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 may be found in the Code of Federal Regarations, our device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA $ Issualitat equr device complies with other requirements of the Act
that FDA has made a determination that your device complies. You must that FDA has made a delemination and regulations administered by other Federal and listing or any Federal statutes and regulations administed to: registration and listing requirements a comply with all the Act S requirements, metals), good manufacturing practice requirements as set
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing the electro (2) CFR Part 807); labellig (21 CFR Patt 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electr torth in the quality systems (QD) regalaten (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1
3
Page 2 - Glenn M. Luchen
This letter will allow you to begin marketing your device as described in your Section 510(k) This icter will anow your to ough finding of substantial equivalence of your device to a legally premarket notification: "The Director on on 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 If you desire specific and Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. halyi Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications Statement
| 510(K)Number(if known): | K041546 |
|---|---|
| ------------------------- | --------- |
Device Name: CF-60DSi
Indications for Use:
(Per 21 CFR 801.109)
aleations for USC.
DIGITAL FUNDUS CAMERA CF-60DSi is intended to be used for taking digital images of retina of human eye with a mydriatic.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERT PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE) 1 OR Over-The-Counter Use Prescription Use
(Optional Format 1-2-96)
Evelyn K. Been
Division Siar Division of Ophthalmic Ear. Nose and Throat 0
510(k) Number K041546