Who is the manufacturer of XRT-7.0?

Elscint, Inc. filed the 510(k) submission for XRT-7.0 (K964583).

What is the FDA product code for XRT-7.0?

JAK. It is classified under 21 CFR 892.1750 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for XRT-7.0?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like XRT-7.0?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

XRT-7.0

K964583 · Elscint, Inc. · JAK · Jan 17, 1997 · Radiology

Device Facts

Record ID	K964583
Device Name	XRT-7.0
Applicant	Elscint, Inc.
Product Code	JAK · Radiology
Decision Date	Jan 17, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1750
Device Class	Class 2

Device Story

XRT-7.0 option for CT Twin flash scanners; adds X-ray tube with 7.0 MHU anode heat capacity. Increases convenience by reducing tube cooling delays. Operated by radiology staff in clinical CT imaging environments. Output is X-ray radiation for diagnostic imaging, consistent with predicate CT scanner functionality.

Clinical Evidence

No clinical data; bench testing only. Safety and effectiveness established via mechanical and electrical similarity to predicate.

Technological Characteristics

X-ray tube with 7.0 MHU anode heat capacity. Integrates with existing CT-Twin flash hardware and software drivers.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

CT-Twin flash (K945512)

Related Devices

K964746 — HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION · GE Medical Systems · Jan 24, 1997
K984156 — SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX W/FLURO OPTION · Shimadzu Medical Systems · Apr 21, 1999
K991553 — SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS W/FLUORO OPTION · Shimadzu Corp. · Jun 8, 1999
K061817 — LIGHTSPEED 7.1 CT SCANNER SYSTEM · Ge Medical Systems, LLC · Jul 12, 2006
K980837 — SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS · Shimadzu Medical Systems · May 20, 1998

Submission Summary (Full Text)

{0} JAN 17 1997 K964583 # Summary of Safety and Effectiveness ## 1. Device Name XRT-7.0 option for CT scanners. ## 2. Submitter Elscint Inc., 505 Main Str. Hackensack, NJ 07601. ## 3. New Features Description XRT-7.0 option was added to CT Twin flash. The option adds an X-ray tube with 7.0 MHU anode heat capacity to the options list. ## 4. Predicate Device CT-Twin flash submitted in “HRSW Option for CT-Twin Flash”, K945512. ## 5. Safety The safety of the device is equivalent to the safety of the predicate device, CT Twin flash. The 7.0 MHU tube option is mechanically and electrically very similar to the previous X-ray tubes and the software driver is the same. ## 6. Effectiveness The effectiveness of the device was not significantly changed in respect to the predicate device, CT Twin flash: The increased heat capacity is more convenient to use due to shorter delays for tube cooling. ## 7. Substantial Equivalency Statement Based on the above considerations, it is Elscint’s opinion that CT scanners with the added XRT-7.0 option is substantially equivalent in safety and effectiveness to its predicate device, CT-Twin flash submitted in “HRSW Option for CT-Twin Flash”, K945512.