MX8000 IDT CT SYSTEM

K012009 · Marconi Medical Systems, Inc. · JAK · Sep 13, 2001 · Radiology

Device Facts

• Record ID: K012009
• Device Name: MX8000 IDT CT SYSTEM
• Applicant: Marconi Medical Systems, Inc.
• Product Code: JAK · Radiology
• Decision Date: Sep 13, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The Mx8000 IDT is a Whole Body Computed Tomography 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 device also includes signal analysis and display equipment, patient and equipment supports, components and accessories.

Device Story

Mx8000 IDT is a whole-body CT scanner featuring a continuously rotating X-ray tube and detector gantry; supports multi-slice acquisition (up to 16 slices simultaneously). Device captures X-ray transmission data at various angles; computer reconstructs data into cross-sectional images. System includes signal analysis, display equipment, and patient/equipment supports. Used in clinical settings by trained medical professionals. Output provides diagnostic cross-sectional images for healthcare providers to interpret, facilitating clinical decision-making and patient diagnosis.

Clinical Evidence

Bench testing only. Safety and effectiveness demonstrated through adherence to GMP, quality assurance procedures, and compliance with IEC 60601-1 (electrical/mechanical safety) and 21 CFR Subchapter J (radiation safety). No clinical data provided.

Technological Characteristics

Whole-body CT scanner; multi-slice (up to 16 slices); rotating X-ray tube and detector gantry. Electrical/mechanical safety per IEC 60601-1. Radiation safety per 21 CFR Subchapter J. Includes signal analysis and display hardware.

Indications for Use

Indicated for whole body computed tomography imaging in patients requiring cross-sectional diagnostic visualization via computer reconstruction of x-ray transmission data.

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

• Mx8000 (initially identified as Volumax) (K982060)
• Mx8000 v5.0 (K010817)

Submission Summary (Full Text)

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# SEP 1 3 2001

# Marconi Medical Systems Inc. 510(k) Summary

## Mx8000 IDT CT Scanner

K012009

### 1. Submitter

Marconi Medical Systems, Inc. 595 Miner Road Cleveland, OH 44143 [phone]

#### Contact:

Robert L. Turocy Marconi Medical Systems 595 Miner Road Cleveland. OH 44143 Telephone: [phone] 483 1116 FAX:

Date of Summary: June 19, 2001

#### 2. Device Name and Classification

Mx8000 IDT CT Scanner Device Name:

Classification Name: Computed Tomography X-Ray System

The FDA has classified the Computed Tomography X-Ray System as Class II in 21 CFR 892.1750 (Product Code 90JAK)

#### 3. Device Description

The Mx8000 IDT is a Whole Body Computed Tomography X-Ray System featuring a continuously rotating X-ray tube and detectors gantry and multi-slice capability of up to 16 slices simultaneously. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. This device also includes signal analysis and display equipment, patient and equipment supports, components and accessories.

### 4. Intended Use Of The Device

The Mx8000 IDT is a Whole Body Computed Tomography 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.

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### 5. Comparison to Predicate Devices

In the opinion of Marconi Medical Systems Inc., the Mx8000 IDT CT scanner is of comparable type and substantially equivalent to the legally marketed devices currently in commercial distribution, namely:

- Mx8000 (initially identified as Volumax), K982060 ●
- . Mx8000 v5.0, K010817

# 6. Safety and Effectiveness Considerations

The safety of the device is assured by adherence to GMP practices and to International Standards. Potential hazards are identified in a hazard analysis and controlled in the following manner:

Software safety is assured by the company procedures that conform to accepted practices. Quality assurance procedures were adhered to, and test results demonstrate that the option specifications and functional requirements were met.

Electrical and Mechanical safety is assured by adherence to IEC 60601-1 standards. Radiation safety is assured by compliance with 21 CFR, Subchapter J performance standards.

### 7. Substantial Equivalency Statement

Based on the above considerations, it is Marconi's opinion that the Mx8000 IDT CT scanner is substantially equivalent in safety and effectiveness to the predicate devices, Mx8000 (initially identified as Volumax), K982060 and Mx8000 v5.0, K010817

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert L. Turocy Regulatory Affairs & Quality Control Marconi Medical Systems, Inc. 595 Miner Road HIGHLAND HEIGHTS OH 44143

Re: K012009 Trade/Device Name: Mx8000 IDT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: 90 JAK Dated: June 19, 2001 Received: June 27, 2001

Dear Mr. Turocy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the encreases 776 the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

SEP 1 3 2001

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 612009 510(k) Number (if known):

Page of

Mx8000 IDT Device Name:

The Mx8000 IDT is a Computed Tomography X-Ray Indications for Use: firdleations for Obe. Bystem intention of x-ray transmission data from the same axial plane taken at rcconsultion of A Ta) addisisess include signal analysis and display equipment, patient, and equipment supports, components and accessories.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <img alt="signature" src="signature.png"/> |
|---------------------------------------------------------------|--------------------------------------------|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K012009 |

| Prescription Use | <div> <img alt="check mark" src="check_mark.png"/> </div> |
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| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter Use | _________________ |
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| (Optional Format 1-2-96) | |