ProKnow DS

GUDID 07340201500057

Elekta Solutions AB

Radiological PACS software

• Primary Device ID: 07340201500057
• NIH Device Record Key: 90de0544-465a-4c82-972a-992b12a4f0eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProKnow DS
• Version Model Number: 2.0
• Company DUNS: 353272181
• Company Name: Elekta Solutions AB
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07340201500057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182855

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2024-03-29
• Device Publish Date: 2024-03-21

Devices Manufactured by Elekta Solutions AB

• 07340201502624 - Leksell Stereotactic System: 2025-08-29 FIXATION SCREW 22,5 MM, TITANIUM
• 07340201502716 - Leksell Stereotactic System: 2025-08-29 FIXATION SCREW 45 MM, TITANIUM
• 07340201502648 - Leksell Stereotactic System: 2025-08-15 FIXATION SCREW 27,5 MM, TITANIUM
• 07340201502693 - Leksell Stereotactic System: 2025-08-15 FIXATION SCREW 40 MM, TITANIUM
• 07340201503478 - Leksell Stereotactic System: 2025-07-29 TITANIUM FIXATION SCREW, KIT 5 PAIRS
• 07340201502280 - Leksell Stereotactic System: 2025-07-18 LEKSELL STEREOTACTIC SYSTEM CLAMP
• 07340201502860 - Leksell Stereotactic System: 2025-07-18 LEKSELL STEREOTACTIC SYSTEM CLAMP, Headrest support, ingoing part of 1040304.
• 07340201502877 - Leksell Stereotactic System: 2025-07-18 LEKSELL STEREOTACTIC SYSTEM CLAMP, Clamp Spacer, ingoing part of 1040304.