CR-PRO

K052938 · Eradlink, Inc. · MQB · Nov 17, 2005 · Radiology

Device Facts

• Record ID: K052938
• Device Name: CR-PRO
• Applicant: Eradlink, Inc.
• Product Code: MQB · Radiology
• Decision Date: Nov 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The CR-Pro is a free standing, laser driven, image digitizer intended to produce digital copies of phosphor plate recorded images in 16 levels of gray scale. The digital copies are transmitted to an internal Intel Pentium 4 based personal computer (PC) where they may be displayed, processed, or compressed for archiving or transmission via computer networks to other medical facility sites. This device is not to be used for primary imaging diagnosis in mammography.

Device Story

eRadlink CR-Pro is a laser-driven digitizing scanner converting radiographic film transparency images (phosphor plates) to digital format. Input: phosphor plates (10-14 inches wide) driven by a clocked stepping motor past a 35mW solid-state laser beam. Fiber optics guide the laser; scanned data is converted to 16-bit digital gray scale. Output: digital images transmitted to an internal Intel Pentium 4 PC for display, processing, or network transmission. Used in clinical settings; operated by healthcare staff. Benefits include accurate, reliable digitization without internal optics cleaning or alignment. Output allows clinicians to archive, transmit, and view images for diagnostic support. Device is not for primary mammography diagnosis.

Clinical Evidence

Bench testing only. Conformance to specifications demonstrated via testing and calibration using Beryllium gray-scale wedges, body part phantoms, and typical x-ray plate samples. No clinical data provided.

Technological Characteristics

Solid-state 35mW laser digitizer; fiber optic beam path; clocked stepping motor drive. 16-bit digital gray scale output. 100μm spot size. Connectivity: USB 2.0, Ethernet. PC-based (Pentium 4, 512MB RAM, Windows XP Pro). Complies with IEC 60601-1, IEC 60601-1-2, and 21 CFR 1040.10 (laser safety).

Indications for Use

Indicated for digitizing phosphor plate radiographic images for display, processing, archiving, or transmission. Not for primary imaging diagnosis in mammography.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• OREX PcCR (K003256)
• LaserPro 16 (K020243)

Submission Summary (Full Text)

{0}------------------------------------------------

1052938

NOV 1 7 2005

Per Title 21 CFR 807. 92, the following is the 510(k) Summary for the Solid State X-ray Imager manufactured and marketed by eRadlink Inc. under the trade-name eRadlink CR-Pro:

- eRadlink Inc. SUBMITTER: (1) 22760 Hawthorne Blvd. Torrance, California 90505-3664 Phone: [phone] Fax:
Albert Kouba CONTACT: Manager, Regulatory Affairs 22760 Hawthorne Blvd. Torrance, California 90505-3664 Phone: [phone] Fax:

30 September 2005 SUBMISSION DATE:

DEVICE NAME: (2)

ﺴ

| TRADE NAME: | eRadlink CR-Pro |
|-----------------------|--------------------------------------------------------------------------------|
| COMMON NAME: | Storage Phosphor Reader with Software Modification |
| CLASSIFICATION NAME: | Solid State X-ray Imager (per regulation 21 CFR 892.1650)<br>(Class II device) |
| PRODUCT CODE: | MQB |
| (3) PREDICATE DEVICE: | OREX PcCR (K003256)<br>49 Plain St.<br>Attleboro, MA 02760 |

#### DEVICE DESCRIPTION: (4)

The eRadlink CR-Pro is a digitizing scanner that converts radiographic film transparency images to digital format. This is accomplished by utilizing a laser beam light source and a proprietary sealed path of fiber optics. The new technology provides superior image quality, requires no internal optics cleaning, no optical alignment and is inherently highly accurate and reliable.

Phosphor plates from a minimum of 10 inches to a maximum of 14 inches in width, is driven past the digitizing laser beam by a clocked, stepping motor. Scanned data is electronically converted from analog to 16 bit digital gray scale and transmitted to the internal computer for processing.

#### INTENDED USE OF DEVICE (5)

The CR-Pro is a free standing, laser driven, image digitizer intended to produce digital copies of phosphor plate recorded images in 16 levels of gray scale. The digital copies are transmitted to an internal Intel Pentium 4 based personal computer (PC) where they may be displayed,

{1}------------------------------------------------

processed, or compressed for archiving or transmission via computer networks to other medical facility sites.

This device is not to be used for primary imaging diagnosis in mammography.

#### SUBSTANTIAL EQUIVALENCE TO PREDICATE DEVICE - HARDWARE (6)

Table -- A illustrates the comparative equivalence of the CR-Pro to the Predicate device Hardware.

| Feature | eRadlink | OREX |
|-------------------|-------------------------------|--------------------------|
| Product Name | CR-Pro | PcCR |
| 510(k) Number | Not Issued | K003256 |
| Dimensions | 40in (h) x 24in(w) x 18in(d) | 16"(h) x 21"(w) x 29"(d) |
| Weight | 98lbs (44.5kg) | 90 lbs. (40.9 kg) |
| Power | 90-227vac 10A 47-63Hz | 110-120vac 1A 50/60 Hz |
| Scan Size | 8" x 10" (min) 14"x 17" (max) | 7" x 7" (min), 14" x 36" |
| Spot Size | 100μm | 100 μm |
| Dynamic Range | 0.0 - 3.5 OD | 0.5 - 3.8 OD |
| Gray Scale | 16 (Transmitted) | 8 or 12 bits |
| Digitizing Rate | 100 lines/sec | 115 lines/sec |
| Laser | 35 mw Solid State | He-Ne Laser |
| Beam Scan | Fiber Optics | Galvanometer |
| Pixel/mm | 8.0 | 10.09 |
| Plate Size | 14" x 17" | 14" x 17" |
| | 14" x 14" | 14" x 14" |
| | 10" x 12" | 10" x 12" |
| | 8" x 10" | 8" x 10" |
| Interface | USB 2 (Diagnostic), Ethernet | USB 1.1 |
| Computer | Pentium 4 2.8 GHz | Pentium 4 1.8 GHz |
| Ram | 512 MB | 512 MB |
| Hard Drive | 80GB | 20 GB |
| Video Card | 2 MB 1024 X 760 Resolution | 1024 X 760 Resolution |
| Monitor | 1024 x 760 | 1024 x 760 |
| Operating System | Windows XP Pro | Windows 2000 |
| Electrical Safety | IEC 60601-1, 2 | IEC 60601-1, 2 |

## Table A – Hardware Comparison of CR-Pro to Predicate Devices

{2}------------------------------------------------

# US 2938

### SUBSTANTIAL EQUIVALENCE TO PREDICATE DEVICE - SOFTWARE (7)

Table B illustrates the comparative equivalence of the CR-Pro to the Predicate device Software.

| Features | eRadlink | OREX | eRadlink² |
|----------------------------------------------------|----------|---------|-----------|
| Product Name | CR-Pro | PcCR | LS-16 |
| 510(k) Number | - | K003256 | K020243 |
| Patient Information - Add/Modify/Delete | Y | Y | Y |
| Fax Report | Y | Y | Y |
| Print Dicom Image | Y | Y | Y |
| Image Rotate and Flip | Y | Y | Y |
| Black/White Inversion | Y | Y | Y |
| Multiple Image Display | Y | Y | Y |
| Dicom Send/Receive/Echo | Y | Y | Y |
| Dicom Query User/Provider | Y | Y | Y |
| Dicom Retrieve User/Provider | Y | Y | Y |
| Dicom Print | Y | Y | Y |
| JPEG Compression lossy/lossless | Y | Y | Y |
| iJPEG Compression | Y | Y | Y |
| Wavelet Compression | Y | Y | Y |
| Industry Standard Digital Communication<br>Support | Y | Y | Y |
| Color Images | N | Y | N |
| Cine Loop Viewing | N | Y | N |
| Dicom Removable Media Support | Y | Y | Y |
| Measurement Tools | Y | Y | Y |
| Communication protocols | Y¹ | Y¹ | Y¹ |

### Table B - Software Comparison of CR-Pro to Predicate Devices

1 ADSL, Cable and Analog Modems and Phone Lines, ATM, ISDN, FDDL, Ethernet, Token Ring

2 The LaserPro 16 (an earlier product of eRadlink) is cited as a Predicate Device as the application software utilized in that device is the same software used in the CR-Pro with minor start-up; phosphor plate handling and erasing modifications.

{3}------------------------------------------------

# K052938

| Color Images | N | Y | N |
|-------------------------------|----|----|----|
| Cine Loop Viewing | N | Y | N |
| Dicom Removable Media Support | Y | Y | Y |
| Measurement Tools | Y | Y | Y |
| Communication protocols | Y1 | Y1 | Y1 |

ADSL, Cable and Analog Modems and Phone Lines, ATM, ISDN, FDDL, Ethernet, Token Ring

2 The LaserPro 16 (an earlier product of eRadlink) is cited as a Predicate Device as the application software utilized in that device is the same software used in the CR-Pro with minor start-up; phosphor plate handling and erasing modifications.

#### EFFECTIVENESS (8)

Program testing and calibration using Beryllium gray-scale wedge, body part phantoms and typical x-ray plate samples has demonstrated the CR-Pro's conformance to its defined specifications.

#### SAFETY (9)

The CR-Pro complies with the following standards:

| Standard:year | Name |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 21CFR1040.10 | PERFORMANCE STANDARDS FOR LIGHT-EMITTING PROD-<br>UCTS: Laser products |
| DICOM 3:2004 | Digital Imaging and Communications in Medicine (including JPEG<br>coding per section 3.6) |
| EN55022:1998 includ-<br>ing A1:2000 | Information technology equipment — Radio disturbance characteris-<br>tics — Limits and methods of measurement |
| EN55024:1998 includ-<br>ing A1:2001 and<br>A2:2003 | Information technology equipment — Immunity characteristics —<br>Limits and methods of measurement |
| EN61000-3-2:2000 | Electromagnetic compatibility (EMC) — Part 3-2: Limits — Limits<br>for harmonic current emissions (equipment input current up to and in-<br>cluding 16 A per phase) |
| EN61000-3-3:1995 in-<br>cluding A1:2001 | Electromagnetic compatibility (EMC) — Part 3-3: Limits — Limita-<br>tion of voltage changes, voltage fluctuations and flicker in public low-<br>voltage supply systems, for equipment with rated current ≤ 16 A per<br>phase and not subject to conditional connection |
| IEC 60601-1:1988 in-<br>cluding am1:1991 and<br>am2:1995 | Medical electrical equipment - Part 1: General requirements for safety |
| IEC 60601-1-2 (2001-<br>09) | Medical electrical equipment - Part 1-2: General requirements for<br>safety - Collateral standard: Electromagnetic compatibility - Require-<br>ments and tests |
| SMPTE RP 215-2001 | Encoding Film Transfer Information into Vertical Ancillary Data for<br>SMPTE 292M Bit-Serial Interface |
| SMPTE 349M-2001 | Television - Transport of Alternate Source Image Formats through<br>SMPTE 292M |

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract emblem that resembles an eagle or bird-like figure with three stylized lines representing its wings or body. The emblem is black, and the text around the perimeter is also in black.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

eRadlink, Inc. % Mr. Ned Devine Responsible Third Party Official Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719

Re: K052938

NOV 1 7 2005

Trade/Device Name: eRadlink CR-Pro Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB

Dated: November 3, 2005 Received: November 4, 2005

Dear Mr. Devine:

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 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) 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 (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 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.

{5}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 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:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincercly 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

: 上一篇:

{6}------------------------------------------------

Indications for Use 510(k) Number (if known):

Device Name: eRadlink CR-Pro

Indications for Use:

The CR-Pro is a free standing, laser driven, image digitizer intended to produce digital copies of phosphor plate recorded images in 16 levels of gray scale. The digital copies are transmitted to an internal Intel Pentium 4 based personal computer (PC) where they may be displayed, processed, or compressed for archiving or transmission via computer networks to other medical facility sites.

This device is not to be used for primary imaging diagnosis in mammography.

Prescription Use (Part 21 CFR 801 Subpart D)

ADIOR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segarra

(Division Sign-Off) Division of Reproductive, Abdominal, a Radiological Devices 510(k) Number

б

Software Certification Statement