ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL

K974423 · Sterling Diagnostic Imaging, Inc. · EAM · Dec 22, 1997 · Radiology

Device Facts

• Record ID: K974423
• Device Name: ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL
• Applicant: Sterling Diagnostic Imaging, Inc.
• Product Code: EAM · Radiology
• Decision Date: Dec 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1960
• Device Class: Class 1

Intended Use

These radiographic intensifying screens have application whenever a high image quality radiographic examination such as mammography is required.

Device Story

Ultra-Vision Mammography Detail and Fast Detail are ultraviolet/blue light emitting, high-definition radiographic intensifying screens. The device utilizes a niobium-activated lutetium tantalate phosphor layer to convert X-ray energy into light for radiographic imaging. Used in clinical settings for mammography procedures, the screens enhance image quality by improving X-ray absorption and modulation transfer function (MTF) compared to traditional gadolinium oxysulfide screens. The device is operated by radiology technicians or physicians to capture high-resolution diagnostic images, facilitating improved visualization of breast tissue for clinical decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparative performance specifications (speed, MTF, and X-ray absorption).

Technological Characteristics

Radiographic intensifying screens; phosphor material: niobium-activated lutetium tantalate; emission spectrum: ultraviolet/blue light; intended for high-definition radiographic imaging.

Indications for Use

Indicated for patients requiring high image quality radiographic examinations, specifically mammography.

Regulatory Classification

Identification

A radiographic intensifying screen is a device that is a thin radiolucent sheet coated with a luminescent material that transforms incident x-ray photons into visible light and intended for medical purposes to expose radiographic film.

Predicate Devices

• Microvision™ Detail

Submission Summary (Full Text)

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K914423
STERLING
Diagnostic Imaging
1

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

DEC 22 1997

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

## SUBMITTED BY:

Jean E. Bartlett
[phone]
Regulatory Affairs and Quality Assurance
STERLING DIAGNOSTIC IMAGING, INC.
PO Box 19048, Mail Drop 102
Greenville, SC 29602-9048
Fax # [phone]

## DEVICE NAME:

Ultra-Vision® Mammography Detail
Ultra-Vision® Mammography Fast Detail

## PREDICATE DEVICE:

Microvision™ Detail

## DEVICE DESCRIPTION AND INTENDED USE:

Ultra-Vision® Mammography Detail and Ultra-Vision® Mammography Fast Detail are ultraviolet/blue light emitting, high definition radiographic intensifying screens. The phosphor is niobium activated lutetium tantalate.

These screens are intended for use in radiographic procedures requiring high levels of image quality such as mammography.

## DEVICE COMPARISON TO PREDICATE DEVICE:

The Ultra-Vision® Mammography Detail and Ultra-Vision® Mammography Fast Detail are substantially equivalent to the Microvision™ Detail as summarized below:

### SUMMARY OF PRODUCT SIMILARITIES/DIFFERENCES

| | Ultra-Vision®Mammography Detail | Ultra-Vision®Mammography Fast Detail | Microvision Detail |
| --- | --- | --- | --- |
| Phosphor | Lutetium Tantalate | Lutetium Tantalate | Gadolinium Oxysulfide |
| Speed | 1.17 | 1.53 | 1.0 |
| MTF @ 4cycles/mm | .675 | .635 | .635 |
| X-ray Absorption @ 25 kVp | .61 | .83 | .60 |
| Imaging Application | High Image quality | High Image quality | Mammography |

Signature: Jean E. Bartlett
Date: 11-19-97

Sterling Diagnostic Imaging, Inc.
10 South Academy Street
P.O. Box 19048
Greenville, SC 29602-9048

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
DEC 22 1997

JeanE Bartlett
Regulatory Affairs &
Compliance Manager
Sterling Diagnostic Imaging, Inc.
10 South Academy Street
P.O. Box 19048
Greenville, SC 29602-9048

Re: K974423
Ultra-vision® Mammography Detail
Ultra-vision® Mammography Fast Detail
Dated: November 21, 1997
Received: November 24, 1997
Regulatory Class: I, Tier II
21 CFR 892.1960/Procode: 90 EAM

Dear Ms. Bartlett:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Enclosure

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# INDICATIONS STATEMENT

510(k) Number (if known): _________________________________________________________

Device Name: Ultra-Vision® Mammography Detail
Ultra-Vision® Mammography Fast Detail

Indications for Use:
These radiographic intensifying screens have application whenever a high image quality radiographic examination such as mammography is required.

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