Identifiers
- 510(k) Number
- K923481 FDA 510(k)
- FDA Product Code
- LMC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2040 FDA 510(k)
- Regulation Number
- 892.2040 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Philips Laser Disk Archive is a radiological multi-format camera device. It is classified as a Class II medical device under regulation number 892.2040 and product code LMC.
It received FDA 510(k) clearance (K923481) on May 5, 1993, as substantially equivalent to a predicate device. The device is manufactured by Philips Medical Systems, Inc. and is intended for use in radiology settings.
Frequently asked questions
What is the Philips Laser Disk Archive used for?
The Philips Laser Disk Archive is a radiological multi-format camera device intended for use in radiology settings to capture and store medical images from various imaging modalities.
How was the Philips Laser Disk Archive cleared for market?
The device received FDA 510(k) clearance (K923481) on May 5, 1993, as substantially equivalent to a predicate device, following a traditional review process.
What regulatory classification does the Philips Laser Disk Archive have?
It is classified as a Class II medical device under regulation number 892.2040 and product code LMC, as determined by the FDA.
Who manufactures the Philips Laser Disk Archive and where is it made?
The device is manufactured by Philips Medical Systems, Inc., with facilities located in Shelton, Connecticut, United States.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Global home | Philips
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K923481 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems, Inc.
Sources (1)
- FDA 510(k) K923481 24 fields · synced Sep 21, 2026