Panoret, Model PNM 60
by Medibell Medical Vision Technologies, Ltd.
510(k) K040325
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK040325 | Date8 Mar 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HKI
- FDA applicant
- Medibell Medical Vision Technologies , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.1120
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Panoret, Model PNM 60 is an ophthalmic camera designed for capturing high-resolution images of the retina and anterior segment of the eye. It is classified as an ac-powered ophthalmic device and is intended for diagnostic imaging in clinical settings, providing detailed visual documentation for ophthalmic assessment.
This device is supplied as a reusable medical instrument and is regulated under 21 CFR 886.1120 as a Class II ophthalmic camera. It requires proper maintenance and sterilization procedures as dictated by clinical protocols, with no specific MRI safety restrictions noted. The Panoret, Model PNM 60 holds FDA 510(k) clearance (K040325) with a decision of Substantially Equivalent, issued on March 8, 2004.
Questions
AI-generated answers, 19 Sep 2026
Is the Panoret, Model PNM 60 designed for capturing images of the entire retina or just specific sections of the eye?
The Panoret, Model PNM 60 is specifically designed to capture high-resolution images of both the retina and the anterior segment of the eye. This dual capability allows clinicians to obtain comprehensive diagnostic visual documentation for ophthalmic assessments, ensuring a thorough examination of the entire eye structure.
How is the Panoret, Model PNM 60 supplied, and what are the requirements for its maintenance and sterilization?
The Panoret, Model PNM 60 is supplied as a reusable medical instrument. Since it is reusable, it must undergo proper maintenance and sterilization procedures as dictated by clinical protocols to ensure safety and functionality. The device does not have specific MRI safety restrictions, but adherence to standard sterilization practices is essential.
What regulatory pathway was followed for the FDA clearance of the Panoret, Model PNM 60, and when was it granted?
The Panoret, Model PNM 60 received FDA clearance through a 510(k) premarket notification process, specifically under the classification of a Class II ophthalmic camera (21 CFR 886.1120). The clearance was granted on March 8, 2004, with a decision of 'Substantially Equivalent' to a predicate device, as part of a special review by the Ophthalmic Devices Advisory Committee.
Does the Panoret, Model PNM 60 come in different sizes or models, and if so, how would one identify them?
The provided data does not specify multiple sizes or models beyond the single model designation, PNM 60. The device is listed under the product code HKI and registration numbers, but no additional variants or sizing options are mentioned. For precise identification, refer to the device’s labeling or manufacturer documentation.