OMNERA 300M

GUDID 00858340006486

The CM-OTC18M is the version of the OMNERA 300M system which uses an overhead tube crane and does not perform synchronized tracking. This x-ray system can perform a comprehensive range of radiographic procedures.

Del Medical, Inc.

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 00858340006486
• NIH Device Record Key: 645ae7f7-3675-4309-bb2d-da2c19c3be00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OMNERA 300M
• Version Model Number: CM-OTC18M
• Company DUNS: 078671236
• Company Name: Del Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858340006486 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223550

FDA Product Code

• KPR: System, X-Ray, Stationary

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-17
• Device Publish Date: 2024-05-09

Devices Manufactured by Del Medical, Inc.

• 00858340006479 - Del Medical, Inc.: 2026-03-13 This a motorized mobile diagnostic x-ray system. The Mobile Direct Radiographic system facilitates x-ray examinations, in situat
• 00858340006523 - Del Medical, Inc.: 2026-03-13 The CM-OTC18T is the version of the DMX system which uses an overhead tube crane and performs synchronized tracking but does not
• 00858340006530 - Del Medical, Inc.: 2026-03-13 The DMX is a stationary, diagnostic X-ray system. This system can perform a comprehensive range of radiographic procedure and is
• 00858340006547 - Del Medical, Inc.: 2026-03-13 The VT300 is a wall-mounted radiographic cassette holder. A wall-mounted radiographic cassette holder is a device that is a supp
• 00858340006486 - OMNERA 300M: 2024-05-17The CM-OTC18M is the version of the OMNERA 300M system which uses an overhead tube crane and does not perform synchronized tracking. This x-ray system can perform a comprehensive range of radiographic procedures.
• 00858340006486 - OMNERA 300M: 2024-05-17 The CM-OTC18M is the version of the OMNERA 300M system which uses an overhead tube crane and does not perform synchronized track
• 00858340006400 - D-EVO Suite FSx: 2024-03-26 The FM-OTC18T is the version of the D-EVO Suite FSx system which uses an overhead tube crane and performs synchronized tracking.
• 00858340006417 - D-EVO Suite FSx: 2024-03-26 The FM-OTC18M is the version of the D-EVO Suite FSx system which uses an overhead tube crane and does not perform synchronized t
• 00858340006424 - D-EVO Suite FSx: 2024-03-26 The FM-FMT18T is the version of the D-EVO Suite FSx system which uses a floor mounted tube stand and performs synchronized track